Method and apparatus for performing catheter-based annuloplasty using local plications

ABSTRACT

A minimally invasive method of performing annuloplasty. According to one aspect, a method for performing annuloplasty includes creating a first plication in the tissue near a mitral valve of a heart, using at least a first plication element, and creating a second plication in the tissue near the mitral valve such that the second plication is substantially coupled to the first plication.

This application is a continuation of PCT/US03/33382 filed on Oct. 21,2003 which claims priority of U.S. Provisional Patent Application No.60/420,095, filed Oct. 21, 2002. The disclosure of each priorityapplication is hereby incorporated by reference herein in its entirety.

CROSS REFERENCE TO RELATED APPLICATIONS

The present invention is related to U.S. Pat. No. 6,619,291 entitled“Method and Apparatus for Catheter-Based Annuloplasty,” filed Apr. 24,2001 and issued Sep. 16, 2003, and to co-pending U.S. patent applicationSer. No. 09/866,550, entitled “Method and Apparatus for Catheter-BasedAnnuloplasty Using Local Plications, which are each incorporated hereinby reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of Invention

The present invention relates generally to techniques for treatingmitral valve insufficiencies such as mitral valve leakage. Moreparticularly, the present invention relates to systems and methods fortreating a leaking mitral valve in a minimally invasive manner.

2. Description of the Related Art

Congestive heart failure (CHF), which is often associated with anenlargement of the heart, is a leading cause of death. As a result, themarket for the treatment of CHF is becoming increasingly prevalent. Forinstance, the treatment of CHF is a leading expenditure of Medicare andMedicaid dollars in the United States of America. Typically, thetreatment of CHF enables many who suffer from CHF to enjoy an improvedquality of life.

Referring initially to FIG. 1, the anatomy of a heart, specifically theleft side of a heart, will be described. The left side of a heart 104includes a left atrium 108 and a left ventricle 112. An aorta 114receives blood from left ventricle 112 through an aortic valve 120,which serves to prevent regurgitation of blood back into left ventricle112. A mitral valve 116 is disposed between left atrium 108 and leftventricle 112, and effectively controls the flow of blood between leftatrium 108 and left ventricle 112.

Mitral valve 116, which will be described below in more detail withrespect to FIG. 2 a, includes an anterior leaflet and a posteriorleaflet that are coupled to cordae tendonae 124 which serve as “tensionmembers” that prevent the leaflets of mitral valve 116 from openingindiscriminately. When left ventricle 112 contracts, cordae tendonae 124allow the anterior leaflet to open upwards until limited in motion bycordae tendonae 124. Normally, the upward limit of opening correspondsto a meeting of the anterior and posterior leaflets and the preventionof backflow. Cordae tendonae 124 arise from a columnae carnae 128 or,more specifically, a musculi papillares of columnae carnae 128.

Left ventricle 112 includes trabeculae 132 which are fibrous cords ofconnective tissue that are attached to wall 134 of left ventricle 112.Trabeculae 132 are also attached to an interventricular septum 136 whichseparates left ventricle 112 from a right ventricle (not shown) of heart104. Trabeculae 132 are generally located in left ventricle 112 belowcolumnae carnae 128.

FIG. 2 a is a cut-away top-view representation of mitral valve 116 andaortic valve 120. Aortic valve 120 has a valve wall 204 that issurrounded by a skeleton 208 a of fibrous material. Skeleton 208 a maygenerally be considered to be a fibrous structure that effectively formsa ring around aortic valve 120. A fibrous ring 208 b, which issubstantially the same type of structure as skeleton 208 a, extendsaround mitral valve 116. Mitral valve 116 includes an anterior leaflet212 and a posterior leaflet 216, as discussed above. Anterior leaflet212 and posterior leaflet 216 are generally thin, flexible membranes.When mitral valve 116 is closed (as shown in FIG. 2 a), anterior leaflet212 and posterior leaflet 216 are generally aligned and contact oneanother to create a seal. Alternatively, when mitral valve 116 isopened, blood may flow through an opening created between anteriorleaflet 212 and posterior leaflet 216.

Many problems relating to mitral valve 116 may occur and theseinsufficiencies may cause many types of ailments. Such problems include,but are not limited to, mitral regurgitation. Mitral regurgitation, orleakage, is the backflow of blood from left ventricle 112 into the leftatrium 108 due to an imperfect closure of mitral valve 116. That is,leakage often occurs when a gap is created between anterior leaflet 212and posterior leaflet 216.

In general, a relatively significant gap may exist between anteriorleaflet 212 and posterior leaflet 216 (as shown in FIG. 2 b) for avariety of different reasons. For example, a gap may exist due tocongenital malformations, because of ischemic disease, or because aheart has been damaged by a previous heart attack. A gap may also becreated when congestive heart failure, e.g., cardiomyopathy, or someother type of distress causes a heart to be enlarged. When a heart isenlarged, the walls of the heart, e.g., wall 134 of a left ventricle,may stretch or dilate, causing posterior leaflet 216 to stretch. Itshould be appreciated that anterior leaflet 212 generally does notstretch. As shown in FIG. 2 b, a gap 220 between anterior leaflet 212and stretched posterior leaflet 216′ is created when wall 134′stretches. Hence, due to the existence of gap 220, mitral valve 116 isunable to close properly, and may begin to leak.

Leakage through mitral valve 116 generally causes a heart to operateless efficiently, as the heart must work harder to maintain a properamount of blood flow therethrough. Leakage through mitral valve 116, orgeneral mitral insufficiency, is often considered to be a precursor toCHF. There are generally different levels of symptoms associated withheart failure. Such levels are classified by the New York HeartAssociation (NYHA) functional classification system. The levels rangefrom a Class 1 level which is associated with an asymptomatic patientwho has substantially no physical limitations to a Class 4 level whichis associated with a patient who is unable to carry out any physicalactivity without discomfort, and has symptoms of cardiac insufficiencyeven at rest. In general, correcting for mitral valve leakage may besuccessful in allowing the NYHA classification grade of a patient to bereduced. For instance, a patient with a Class 4 classification may havehis classification reduced to Class 3 and, hence, be relativelycomfortable at rest.

Treatments used to correct for mitral valve leakage or, more generally,CHF, are typically highly invasive, open-heart surgical procedures.Ventricular assist devices such as artificial hearts may be implanted ina patient whose own heart is failing. The implantation of a ventricularassist device is often expensive, and a patient with a ventricularassist device must be placed on extended anti-coagulant therapy. As willbe appreciated by those skilled in the art, anti-coagulant therapyreduces the risk of blood clots being formed, as for example, within theventricular assist device. While reducing the risks of blood clotsassociated with the ventricular assist device is desirable,anti-coagulant therapies may increase the risk of uncontrollablebleeding in a patient, e.g., as a result of a fall, which is notdesirable.

Rather than implanting a ventricular assist device, bi-ventricularpacing devices similar to pace makers may be implanted in some cases,e.g., cases in which a heart beats inefficiently in a particularasynchronous manner. While the implantation of a bi-ventricular pacingdevice may be effective, not all heart patients are suitable forreceiving a bi-ventricular pacing device. Further, the implantation of abi-ventricular pacing device is expensive.

Open-heart surgical procedures which are intended to correct for mitralvalve leakage, specifically, involve the implantation of replacementvalves. Valves from animals, e.g., pigs, may be used to replace a mitralvalve 116 in a human. While the use of a pig valve may relativelysuccessfully replace a mitral valve, such valves generally wear out,thereby requiring additional open surgery at a later date. Mechanicalvalves, which are less likely to wear out, may also be used to replace aleaking mitral valve. However, when a mechanical valve is implanted,there is an increased risk of thromboembolism, and a patient isgenerally required to undergo extended anti-coagulant therapies.

A less invasive surgical procedure involves heart bypass surgeryassociated with a port access procedure. For a port access procedure,the heart may be accessed by cutting a few ribs, as opposed to openingthe entire chest of a patient. In other words, a few ribs may be cut ina port access procedure, rather than opening a patient's sternum.

One open-heart surgical procedure that is particularly successful incorrecting for mitral valve leakage and, in addition, mitralregurgitation, is an annuloplasty procedure. During an annuloplastyprocedure, an annuloplasty ring may be implanted on the mitral valve tocause the size of a stretched mitral valve 116 to be reduced to arelatively normal size. FIG. 3 is a schematic representation of anannuloplasty ring. An annuloplasty ring 304 is shaped approximately likethe contour of a normal mitral valve. That is, annuloplasty ring 304 isshaped substantially like the letter “D.” Typically, annuloplasty ring304 may be formed from a rod or tube of biocompatible material, e.g.,plastic, that has a DACRON mesh covering.

In order for annuloplasty ring 304 to be implanted, a surgeon surgicallyattaches annuloplasty ring 304 to the mitral valve on the atrial side ofthe mitral valve. Conventional methods for installing ring 304 requireopen-heart surgery which involve opening a patient's sternum and placingthe patient on a heart bypass machine. As shown in FIG. 4, annuloplastyring 304 is sewn to a posterior leaflet 318 and an anterior leaflet 320of a top portion of mitral valve 316. In sewing annuloplasty ring 304onto mitral valve 316, a surgeon generally alternately acquires arelatively large amount of tissue from mitral tissue, e.g., a one-eighthinch bite of tissue, using a needle and thread, followed by a smallerbite from annuloplasty ring 304. Once a thread has loosely coupledannuloplasty ring 304 to mitral valve tissue, annuloplasty ring 304 isslid onto mitral valve 316 such that tissue that was previouslystretched out, e.g., due to an enlarged heart, is effectively pulled inusing tension applied by annuloplasty ring 304 and the thread whichbinds annuloplasty ring 304 to the mitral valve tissue. As a result, agap, such as gap 220 of FIG. 2 b, between anterior leaflet 320 andposterior leaflet 318 may be substantially closed off. After the mitralvalve is shaped by ring 304, the anterior and posterior leaflets 320,318 will reform to create a new contact line and will enable mitralvalve 318 to appear and to function as a normal mitral valve.

Once implanted, tissue generally grows over annuloplasty ring 304, and aline of contact between annuloplasty ring 304 and mitral valve 316 willessentially enable mitral valve 316 to appear and function as a normalmitral valve. Although a patient who receives annuloplasty ring 304 maybe subjected to anti-coagulant therapies, the therapies are notextensive, as a patient is only subjected to the therapies for a matterof weeks, e.g., until tissue grows over annuloplasty ring 304.

A second surgical procedure which is generally effective in reducingmitral valve leakage involves placing a single edge-to-edge suture inthe mitral valve. With reference to FIG. 5 a, such a surgical procedure,e.g., an Alfieri stitch procedure or a bow-tie repair procedure, will bedescribed. An edge-to-edge stitch 404 is used to stitch together an areaat approximately the center of a gap 408 defined between an anteriorleaflet 420 and a posterior leaflet 418 of a mitral valve 416. Oncestitch 404 is in place, stitch 404 is pulled in to form a suture whichholds anterior leaflet 420 against posterior leaflet 418, as shown. Byreducing the size of gap 408, the amount of leakage through mitral valve416 may be substantially reduced.

Although the placement of edge-to-edge stitch 404 is generallysuccessful in reducing the amount of mitral valve leakage through gap408, edge-to-edge stitch 404 is conventionally made through open-heartsurgery. In addition, the use of edge-to-edge stitch 404 is generallynot suitable for a patient with an enlarged, dilated heart, as bloodpressure causes the heart to dilate outward, and may put a relativelylarge amount of stress on edge-to-edge stitch 404. For instance, bloodpressure of approximately 120/80 or higher is typically sufficient tocause the heart to dilate outward to the extent that edge-to-edge stitch404 may become undone, or tear mitral valve tissue.

Another surgical procedure which reduces mitral valve leakage involvesplacing sutures along a mitral valve annulus around the posteriorleaflet. A surgical procedure which places sutures along a mitral valvewith be described with respect to FIG. 5 b. Sutures 504 are formed alongan annulus 540 of a mitral valve 516 around a posterior leaflet 518 ofmitral valve 516, and may be formed as a double track, e.g., in two“rows,” from a single strand of suture material. Sutures 504 are tiedoff at approximately a central point 506 of posterior leaflet 518.Pledgets 546 are often positioned under selected sutures 504, e.g., atcentral point 506, to prevent sutures 504 from tearing through annulus540. When sutures 504 are tied off, annulus 540 may effectively betightened to a desired size such that the size of a gap 508 betweenposterior leaflet 518 and an anterior leaflet 520 may be reduced.

The placement of sutures 504 along annulus 540, in addition to thetightening of sutures 504, is generally successful in reducing mitralvalve leakage. However, the placement of sutures 504 is conventionallyaccomplished through open-heart surgical procedures. That is, like otherconventional procedures, a suture-based annuloplasty procedure isinvasive.

While invasive surgical procedures have proven to be effective in thetreatment of mitral valve leakage, invasive surgical procedures oftenhave significant drawbacks. Any time a patient undergoes open-heartsurgery, there is a risk of infection. Opening the sternum and using acardiopulmonary bypass machine has also been shown to result in asignificant incidence of both short and long term neurological deficits.Further, given the complexity of open-heart surgery, and the significantassociated recovery time, people who are not greatly inconvenienced byCHF symptoms, e.g., people at a Class 1 classification, may choose notto have corrective surgery. In addition, people who most need open heartsurgery, e.g., people at a Class 4 classification, may either be toofrail or too weak to undergo the surgery. Hence, many people who maybenefit from a surgically repaired mitral valve may not undergo surgery.

Therefore, what is needed is a minimally invasive treatment for mitralvalve leakage. Specifically, what is desired is a method for reducingleakage between an anterior leaflet and a posterior leaflet of a mitralvalve that does not require conventional surgical intervention.

SUMMARY OF THE INVENTION

The present invention relates to a non-invasive method of performingannuloplasty. Performing an annuloplasty on a mitral valve by accessingthe left ventricle of the heart, as for example using a catheter,enables complicated surgical procedures to be avoided when treatingmitral valve leakage. Avoiding open-heart surgical procedures generallymakes annuloplasty more accessible to patients who may benefit fromannuloplasty. As mitral valve leakage is often considered to be an earlyindicator of congestive heart failure, a minimally invasive annuloplastyprocedure that corrects for leakage problems, such as one which involvespositioning discrete plications in fibrous tissue around the mitralvalve, may greatly improve the quality of life of many patients whomight not be suitable for invasive annuloplasty procedures.

According to one aspect of the present invention, a method forperforming annuloplasty includes creating a first plication in thetissue near a mitral valve of a heart, using at least a first plicationelement, and creating a second plication in the tissue near the mitralvalve such that the second plication is substantially coupled to thefirst plication. In one embodiment, the method also includes accessing aleft ventricle of the heart to provide the first plication element tothe left ventricle, and engaging the first plication element to thetissue near the mitral valve. Engaging the first plication elementincludes causing the first plication element to substantially passthrough a portion of the tissue to substantially anchor the firstplication element to the tissue near the mitral valve.

According to another aspect of the present invention, a method forperforming annuloplasty includes accessing a heart to provide aplurality of plication elements to the heart. The plurality of plicationelements are provided to the heart through a catheter arrangement, andinclude a first anchor arrangement. The method also includes engagingthe first anchor arrangement to tissue near a mitral valve of the heartusing the catheter arrangement by causing the first anchor arrangementto substantially pass through the tissue to substantially anchor thefirst anchor arrangement to the tissue near the mitral valve. Finally,the method includes creating at least a first plication and a secondplication using the first anchor arrangement.

In accordance with still another embodiment of the present invention, amethod for performing annuloplasty includes accessing an area of a heartto provide a first plication element to the area using a catheterarrangement which has a first portion and a second portion, andsubstantially anchoring the first portion of the catheter arrangement totissue near a mitral valve of the heart. The method further includespositioning a tip of the second portion of the catheter arrangement at afirst distance from the first portion, and substantially engaging thefirst anchor to the tissue near the mitral valve of the heart using thesecond portion of the catheter arrangement. Substantially engaging thefirst anchor includes causing the first anchor to substantially passthrough a portion of the tissue to substantially anchor the first anchorto the tissue near the mitral valve using the second portion of thecatheter arrangement. In one embodiment, substantially anchoring thefirst portion of the catheter arrangement to tissue near the mitralvalve of the heart includes positioning the first portion of thecatheter arrangement over a guide that is at least temporarily anchoredto the tissue near the mitral valve.

These and other advantages of the present invention will become apparentupon reading the following detailed descriptions and studying thevarious figures of the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may best be understood by reference to the followingdescription taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is a cross-sectional front-view representation of the left sideof a human heart.

FIG. 2 a is a cut-away top-view representation of the mitral valve andthe aortic valve of FIG. 1.

FIG. 2 b is a cut-away representation of a stretched mitral valve and anaortic valve.

FIG. 3 is a representation of an annular ring that is suitable for usein performing a conventional annuloplasty procedure.

FIG. 4 is a representation of a mitral valve and an aortic valve afterthe annular ring of FIG. 3 has been implanted.

FIG. 5 a is a representation of a mitral valve and an aortic valve aftera single edge-to-edge suture has been applied to reduce mitralregurgitation.

FIG. 5 b is a representation of a mitral valve and an aortic valve aftersutures along a mitral valve annulus have been applied to reduce mitralregurgitation.

FIG. 6 a is a representation of a delivery tube and a J-catheter inaccordance with an embodiment of the present invention.

FIG. 6 b is a cut-away front view of the left side of a heart in whichthe delivery tube and the J-catheter of FIG. 6 a have been inserted inaccordance with an embodiment of the present invention.

FIG. 7 a is a representation of a catheter assembly in accordance withan embodiment of the present invention.

FIG. 7 b is a cross-sectional representation of the catheter assembly ofFIG. 7 a in accordance with an embodiment of the present invention.

FIG. 7 c is a cut-away top-view representation of a left ventricle inwhich the gutter catheter of FIGS. 7 a and 7 b has been positioned inaccordance with an embodiment of the present invention.

FIG. 8 is a cut-away top-view representation of a left ventricle inwhich a guide wire has been positioned in accordance with an embodimentof the present invention.

FIG. 9 a is a cut-away top-view representation of a left ventricle ofthe heart in which local plication suture structures have been implantedin accordance with an embodiment of the present invention.

FIG. 9 b is a cut-away top-view representation of a left ventricle ofthe heart in which local plication suture structures which are coupledhave been implanted in accordance with an embodiment of the presentinvention.

FIG. 10 a is a representation of a suture structure after T-bars havebeen introduced to an atrial side of a mitral valve through fibroustissue near the mitral valve in accordance with an embodiment of thepresent invention.

FIG. 10 b is a representation of the suture structure of FIG. 10 a afterthe T-bars have been engaged to the fibrous tissue in accordance with anembodiment of the present invention.

FIG. 11 is a representation of a suture structure which includes alocking element with a spring in accordance with an embodiment of thepresent invention.

FIG. 12 a is a representation of a suture structure which includes alocking element with a resorbable component in accordance with anembodiment of the present invention.

FIG. 12 b is a representation of the suture structure of FIG. 12 a afterthe resorbable component has degraded in accordance with an embodimentof the present invention.

FIG. 12 c is a representation of the suture structure of FIG. 12 b aftera plication has been created in accordance with an embodiment of thepresent invention.

FIG. 13 a is a representation of a first catheter which is suitable foruse in delivering and implementing a suture structure in accordance withan embodiment of the present invention.

FIG. 13 b is a representation of a second catheter which is suitable foruse in delivering and implementing a suture structure in accordance withan embodiment of the present invention.

FIG. 13 c is a representation of a third catheter assembly which issuitable for use in delivering and implementing a suture structure inaccordance with an embodiment of the present invention.

FIGS. 14 a and 14 b are a process flow diagram which illustrates thesteps associated with one method of performing annuloplasty using asuture structure and a catheter in accordance with an embodiment of thepresent invention.

FIG. 15 is a cut-away top-view representation of a left ventricle of theheart in which local plication elements have been implanted inaccordance with an embodiment of the present invention.

FIG. 16 a is a representation of a local plication element which hasspring-like characteristics in accordance with an embodiment of thepresent invention.

FIG. 16 b is a representation of the local plication element of FIG. 16a after forces have been applied to open the local plication element inaccordance with an embodiment of the present invention.

FIG. 16 c is a representation of the local plication element of FIG. 16b after tips of the local plication element pierce through tissue inaccordance with an embodiment of the present invention.

FIG. 16 d is a representation of the local plication element of FIG. 16c after the tips of the local plication element engage the tissue toform a local plication in accordance with an embodiment of the presentinvention.

FIG. 17 a is a representation of a local plication element, which isformed from a shape memory material, in an open state in accordance withan embodiment of the present invention.

FIG. 17 b is a representation of the local plication element of FIG. 17a in a closed state in accordance with an embodiment of the presentinvention.

FIG. 18 a is a representation of a first self-locking clip which issuitable for use in forming a local plication in accordance with anembodiment of the present invention.

FIG. 18 b is a representation of a second self-locking clip which issuitable for use in forming a local plication in accordance with anembodiment of the present invention.

FIG. 19 is a representation of a plication-creating locking mechanism inaccordance with an embodiment of the present invention.

FIG. 20 a is a representation of the plication-creating lockingmechanism of FIG. 19 as provided within the left ventricle of a heart inaccordance with an embodiment of the present invention.

FIG. 20 b is a representation of the plication-creating lockingmechanism of FIG. 20 a after forces have been applied to cause tines ofthe mechanism to contact tissue in accordance with an embodiment of thepresent invention.

FIG. 20 c is a representation of the plication-creating lockingmechanism of FIG. 20 b after tissue has been gathered between the tinesof the mechanism in accordance with an embodiment of the presentinvention.

FIG. 20 d is a representation of the plication-creating lockingmechanism of FIG. 20 c after a local plication has been formed inaccordance with an embodiment of the present invention.

FIGS. 21 a and 21 b are a process flow diagram which illustrates thesteps associated with one method of performing annuloplasty using alocal plication element and a catheter in accordance with an embodimentof the present invention.

FIG. 22 a is a cut-away front view of the left side of a heart in whichan L-shaped catheter has been inserted in accordance with an embodimentof the present invention.

FIG. 22 b is a cut-away front view of the left side of a heart in whichan L-shaped catheter has been inserted and extended in accordance withan embodiment of the present invention.

FIG. 22 c is a cut-away front view of the left side of a heart in whichan L-shaped catheter has been inserted, extended, and curved inaccordance with an embodiment of the present invention.

FIG. 23 a is representation of a portion of a first catheter which mayuse suction to engage against tissue in accordance with an embodiment ofthe present invention.

FIG. 23 b is representation of a portion of a first catheter which mayuse suction to engage against tissue in accordance with an embodiment ofthe present invention.

FIG. 24 a is representation of a portion of a wire with a helical coilwhich may be used as a temporary anchor in accordance with an embodimentof the present invention.

FIG. 24 b is representation of a portion of a catheter with a helicalcoil which may be used as a temporary anchor in accordance with anembodiment of the present invention.

FIG. 25 is a representation of an anchor which is deployed and anchoredinto tissue in accordance with an embodiment of the present invention.

FIG. 26 a is a representation of a portion of an incrementor catheter ina closed configuration which is positioned over a tail of an anchor inaccordance with an embodiment of the present invention.

FIG. 26 b is a representation of a portion of an incrementor catheter inan open configuration which is positioned over a tail and is extendedsuch that a first section and a second section of the incrementor havetips that are separated by a distance in accordance with an embodimentof the present invention.

FIG. 27 is a representation of two anchors which may be used to create aplication in accordance with an embodiment of the present invention.

FIGS. 28 a-f are representations of anchors and lockers which are usedin a process of creating a daisy chain of plications in accordance withan embodiment of the present invention.

FIG. 29 a is a cut-away front view of the left side of a heart in whicha hook catheter has been inserted in accordance with an embodiment ofthe present invention.

FIG. 29 b is a cut-away front view of the left side of a heart in whicha hook catheter is positioned beneath a mitral valve in accordance withan embodiment of the present invention.

FIG. 29 c is a cut-away front view of the left side of a heart in whicha temporary anchor has been inserted in accordance with an embodiment ofthe present invention.

FIG. 29 d is a cut-away front view of the left side of a heart in whicha hook catheter which carries a permanent anchor is inserted inaccordance with an embodiment of the present invention.

FIG. 29 e is a cut-away front view of the left side of a heart in whicha permanent anchor has been inserted in accordance with an embodiment ofthe present invention.

FIG. 29 f is a cut-away front view of the left side of a heart in whichan incrementor catheter has been inserted in accordance with anembodiment of the present invention.

FIG. 29 g is a cut-away front view of the left side of a heart in whichtwo permanent anchors have been inserted in accordance with anembodiment of the present invention.

FIG. 29 h is a cut-away front view of the left side of a heart in whichtwo permanent anchors and a locking device or locker have been insertedin accordance with an embodiment of the present invention.

FIG. 30 is a process flow diagram which illustrates the steps associatedwith one method of creating a plication using an incrementor catheter inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Invasive, open-heart surgical procedures are generally effective in thetreatment of mitral valve leakage. However, open-heart surgicalprocedures may be particularly hazardous to some patients, e.g., frailpatients or patients who are considered as being very ill, andundesirable to other patients, e.g., patients who are asymptomatic anddo not wish to undergo a surgical procedure. As such, open-heartsurgical procedures to correct mitral valve leakage or, more generally,mitral valve insufficiency, are not suitable for many patients who wouldlikely benefit from reducing or eliminating the mitral valve leakage.

A catheter-based annuloplasty procedure enables annuloplasty to beperformed on a patient without requiring that the patient undergoopen-heart surgery, or be placed on cardiopulmonary bypass. Cathetersmay be introduced into the left ventricle of a heart through the aortato position a guide wire and plication implants on the ventricular sideof a mitral valve, i.e., under a mitral valve. Catheters may also beused to couple the plication implants to fibrous tissue associated withthe skeleton of the heart around the mitral valve.

The use of catheters to perform an annuloplasty procedure by deliveringand engaging plication implants or structures enables the annuloplastyprocedure to be performed without open-heart surgery, and without abypass procedure. Recovery time associated with the annuloplasty, aswell as the risks associated with annuloplasty, may be substantiallyminimized when the annuloplasty is catheter-based. As a result,annuloplasty becomes a more accessible procedure, since many patientswho might previously not have received treatment for mitral valveleakage, e.g., frail patients and asymptomatic patients, may choose toundergo catheter-based annuloplasty.

To begin a catheter-based annuloplasty procedure, a delivery tube and aJ-catheter may be inserted into a left ventricle of the heart throughthe aorta. Inserting the delivery tube and the J-catheter through theaorta enables the left ventricle of the heart to be reachedsubstantially without coming into contact with trabeculae or the cordaetendonae in the left ventricle. FIG. 6 a is a diagrammaticrepresentation of a delivery tube and a J-catheter in accordance with anembodiment of the present invention. Delivery tube 604 has asubstantially circular cross section, and is configured to receive aJ-catheter 608. J-catheter 608 is arranged to move longitudinallythrough and opening in delivery tube 604 as needed.

In general, delivery tube 604 is an elongated body which may be formedfrom a flexible, durable, biocompatible material such as nylon,urethane, or a blend of nylon and urethane, e.g., PEBAX®. Likewise,J-catheter 608, which is also an elongated body, may also be formed froma biocompatible material. A material used to form J-catheter 608 istypically also relatively flexible. In the described embodiment, a tipof J-catheter 608 is rigid enough to allow the tip of J-catheter 608 tomaintain a relatively curved shape, e.g., a “J” shape. The curve inJ-catheter 608 is configured to facilitate the positioning of a guttercatheter, as will be described below with respect to FIGS. 7 a-c.

FIG. 6 b is a schematic representation of delivery tube 604 andJ-catheter 608 positioned within a heart in accordance with anembodiment of the present invention. As shown, after delivery tube 604and J-catheter 608 are effectively “snaked” or inserted through afemoral artery, portions of delivery tube 604 and of J-catheter 608 arepositioned within an aorta 620 of a heart 616. A tip 626 of J-catheter608, which is substantially oriented at a right angle from the body ofJ-catheter 608, and an end of delivery tube 604 are oriented such thatthey pass through an aortic valve 630. Hence, an end of delivery tube604 and tip 626 are positioned at a top portion of left ventricle 624,where wall 632 of left ventricle 624 is relatively smooth. The relativesmoothness of the top portion of left ventricle 624 enables a catheterto be properly positioned within left ventricle 624 by guiding the tipof the catheter along wall 632. In one embodiment, tip 626 is orientedsuch that it is positioned approximately just below a mitral valve 628on the ventricular side of mitral valve 628.

Once positioned within left ventricle 624, J-catheter 608 may be rotatedwithin delivery tube 604 such that tip 626 is may enable a guttercatheter fed therethrough to run along the contour of wall 632.Typically, the gutter catheter runs along the contour of wall 632 in anarea that is effectively defined between a plane associated withpapillary muscles 640, a plane associated with the posterior leaflet ofmitral valve 628, cordae tendonae 642, and wall 632. A “gutter” islocated in such an area or region and, more specifically, is positionedsubstantially right under mitral valve 628 where there is a relativelyinsignificant amount of trabeculae.

With reference to FIGS. 7 a-7 c, a gutter catheter will be described inaccordance with an embodiment of the present invention. A guttercatheter 704, which is part of a catheter assembly 702 as shown in FIG.7 a, is arranged to be extended through J-catheter 626 such that guttercatheter 704 may be steered within a left ventricle just beneath amitral valve. Gutter catheter 704, which may include a balloon tip (notshown), is typically formed from a flexible material such as nylon,urethane, or PEBAX®. In one embodiment, gutter catheter 704, which issteerable, may be formed using a shape memory material.

As shown in FIG. 7 a and FIG. 7 b, which represents a cross section ofcatheter assembly 702 taken at a location 710, gutter catheter 704 is atleast partially positioned within J-catheter 608 which, in turn, is atleast partially positioned within delivery tube 604. Gutter catheter 704may be free to rotate within and extend through J-catheter 608, whileJ-catheter 608 may be free to rotate within and extend through deliverytube 604.

Referring next to FIG. 7 c, the positioning of gutter catheter 704within a left ventricle of the heart will be described in accordancewith an embodiment of the present invention. It should be appreciatedthat the representation of gutter catheter 704 within a left ventricle720 has not been drawn to scale, for ease of illustration and ease ofdiscussion. For instance, the distance between a wall 724 of leftventricle 720 and a mitral valve 728 has been exaggerated. In addition,it should also be appreciated that the positioning of delivery tube 604and, hence, J-catheter 608 and gutter catheter 704 within aortic valve732 may vary.

Gutter catheter 704 protrudes through tip 626 of J-catheter 608, and,through steering, essentially forms an arc shape similar to that ofmitral valve 728 along the contour of a wall 724 of left ventricle 720just beneath mitral valve 728, i.e., along the gutter of left ventricle720. Wall 724 of left ventricle 720 is relatively smooth just beneathmitral valve 728, i.e., generally does not include trabeculae. Hence,inserting catheter assembly 702 through an aortic valve 732 into anupper portion left ventricle 720 allows gutter catheter 704 to benavigated within left ventricle 720 along wall 724 substantially withoutbeing obstructed by trabeculae or cordae tendonae.

Gutter catheter 704 generally includes an opening or lumen (not shown)that is sized to accommodate a guide wire through which a guide wire maybe inserted. The opening may be located along the central axis of guttercatheter 704, i.e., central axis 730 as shown in FIG. 7 a. Delivering aguide wire through gutter catheter 704 enables the guide wire toeffectively follow the contour of wall 724. In general, the guide wiremay include an anchoring tip which enables the guide wire to besubstantially anchored against wall 724. FIG. 8 is a diagrammatictop-view cut-away representation of a left side of a heart in which aguide wire has been positioned in accordance with an embodiment of thepresent invention. It should be appreciated that the representation ofthe left side of a heart in FIG. 8 has not been drawn to scale, and thatvarious features have been exaggerated for ease of discussion. A guidewire 802 is positioned along wall 724 of left ventricle 720. Once guidewire 802 is inserted through gutter catheter 704 of FIGS. 7 a-7 c, andanchored against wall 724 using an anchoring tip 806, gutter catheter704, along with J-catheter 708, are withdrawn from the body of thepatient. It should be appreciated that delivery tube 604 typicallyremains positioned within the aorta after guide wire 802 is anchored towall 724.

Guide wire 802, which may be formed from a material such as stainlesssteel or a shape memory material, is generally anchored such that guidewire 802 effectively passes along a large portion of wall 724.Typically, guide wire 802 serves as a track over which a catheter thatcarries plication structures may be positioned, i.e., a lumen of acatheter that delivers a plication element may pass over guide wire 802.Such a catheter may include a balloon structure (not shown), or anexpandable structure, that may facilitate the positioning of localplication structures by pushing the local plication structuressubstantially against the fibrous tissue around the mitral valve.

Forming local plications causes bunches of the fibrous tissue around themitral valve to be captured or gathered, thereby causing dilation of themitral valve to be reduced. In general, the local plications arediscrete plications formed in the fibrous tissue around the mitral valveusing suture structures or discrete mechanical elements. FIG. 9 a is arepresentation of a top-down cut-away view of a left ventricle of theheart in which local plication suture structures have been implanted inaccordance with an embodiment of the present invention. Suturestructures, which include T-bars 904 and threads 907, are implanted intissue near a mitral valve 916, e.g., an annulus of mitral valve 916.Typically, the tissue in which suture structures are implanted isfibrous tissue 940 which is located substantially around mitral valve916. Suitable suture structures include, but are not limited to,structures which include T-bars 904 and threads 907, as will bedescribed below with reference to FIGS. 10 a, 10 b, 11, and 12 a-c.

Since T-bars 904 or similar structures, when implanted, may cut throughtissue 940, pledgets 905 may against a ventricular side tissue 940 toeffectively “cushion” T-bars 904. Hence, portions of T-bars 904 arepositioned above mitral valve 916, i.e., on an atrial side of mitralvalve 916, while pledgets 905 are positioned on the ventricular side ofmitral valve 916. It should be appreciated that additional oralternative pledgets may be positioned on the atrial side of mitralvalve 916, substantially between tissue 940 and T-bars 904. Catheterswhich deliver suture structures 904 to an atrial side of mitral valve916 from a ventricular side of mitral valve 916 will be discussed belowwith respect to FIGS. 13 a-c.

In the described embodiment, T-bars 904 are coupled such that every twoT-bars, e.g., T-bars 904 a, is coupled by a thread, e.g., thread 907 a.Thread 907 a is configured to enable T-bars 904 a to be tensionedtogether and locked against tissue 940. Locking T-bars 904 a enablestissue 940 to be bunched or slightly gathered, thereby effectivelyconstraining the size, e.g., arc length, of mitral valve 916 by reducingthe an arc length associated with tissue 940. In other words, thepresence of T-bars 904 which cooperate with thread 907 to functionsubstantially as sutures, allows the size of a gap 908 between ananterior leaflet 920 and a posterior leaflet 918 to be reduced and,further, to be substantially prevented from increasing. As will beappreciated by those skilled in the art, over time, scar tissue (notshown) may form over pledgets 905 and T-bars 904.

Generally, the number of T-bars 904 used to locally bunch or gathertissue 940 may be widely varied. For instance, when substantially only asmall, localized regurgitant jet occurs in mitral valve 916, only asmall number of T-bars 904 may be implemented in proximity to theregurgitant jet. Alternatively, when the size of gap 908 is significant,and there is a relatively large amount of mitral valve leakage, then arelatively large number of T-bars 904 and, hence, pledgets 905 may beused to reduce the size of gap 908 by reducing the arc length of mitralvalve 916. Some pledgets 905 may be arranged to at least partiallyoverlap. To correct for a regurgitant jet that is centralized to onlyone section of mitral valve 916, T-bars 904 may be implemented asplicating elements near the regurgitant jet, and as reinforcing elementsaway from the regurgitant jet, e.g., to prevent progression of mitralvalve disease from causing a substantial gap to eventually form.

While the coupling of two T-bars 904 a with thread 907 a has beendescribed, it should be understood that the number of T-bars 904 coupledby a thread or threads 907 may vary. For example, if multiple T-bars 904are coupled by multiple threads 907, then it may be possible to gathermore fibrous tissue using fewer total T-bars 904. With reference to FIG.9 b, the use of multiple T-bars 904 which are coupled by multiplethreads 907 will be described. T-bars 904 c are coupled by a thread 907c, while T-bars 904 d are coupled by a thread 907 c. Similarly, T-bars904 e are coupled by a thread 907 e. T-bar 904 d′ is further coupled bya thread 907 f to T-bar 904 c″, and T-bars 904 d″ is also coupled by athread 907 g to T-bar 904 e′. As will be discussed below, threads 907enable T-bars 904 to be pulled against pledgets 905 and, hence, tissue940. Such coupling of T-bars 904 enables plications in tissue 940 to bemade between T-bars 904 c, between T-bars 904 d, and between T-bars 904e, while allowing tissue to be at least somewhat gathered between T-bar904 c″ and T-bar 904 d′, and between T-bar 904 d″ and T-bar 904 e′.

In general, the configurations of suture structures which include T-bars904 and threads 907 may vary. One embodiment of a suitable suturestructure is shown in FIGS. 10 a and 10 b. FIGS. 10 a and 10 b arerepresentations of a suture structure after T-bars have been introducedto an atrial side of fibrous tissue near a mitral valve in accordancewith an embodiment of the present invention. For purposes ofillustration, it should be understood that the elements and structuresrepresented in FIGS. 10 a and 10 b, as well as substantially all otherfigures, have not been drawn to scale. A suture structure 1000 includesT-bars 904, or reinforcing elements, that are coupled to thread 907 suchthat when thread 907 is pulled, T-bars 904 effectively push againsttissue 940. As shown in FIG. 10 b, pulling on thread 907 and pushing ona locking element 1002 causes locking element 1002 to contact aventricular side of tissue 940 and to effectively hold T-bars 904against tissue 940. Specifically, pulling on a loop 1004 of thread 907while pushing on locking element 1002 tightens T-bars 904 against tissue940 such that a plication 1006 may be formed in tissue 940 when lockingelement 1002 locks into position to lock T-bars 904 into place.

Pledgets 905, as will be appreciated by those skilled in the art, mayserve as plication anchors for T-bars 904 which essentially function assutures. That is, pledgets 905 may prevent T-bars 904 from cuttingthrough tissue 940. In general, the configuration of pledgets 905 mayvary widely. For example, pledgets 905 may have a substantially tubularform, and may be formed from a material such as surgical, e.g., Dacron,mesh. However, it should be appreciated that pledgets 905 may be formedin substantially any shape and from substantially any material whichpromotes or supports the growth of scar tissue therethrough. Suitablematerials include, but are not limited to silk and substantially anybiocompatible porous or fibrous material.

Locking element 1002 may be a one-way locking element, e.g., an elementwhich may not be easily unlocked once it is locked, that is formed froma biocompatible polymer. The configuration of a locking element 1002 maybe widely varied. Alternative configurations of locking element 1002will be described below with respect to FIG. 11 and FIGS. 12 a-c. Inorder to engage locking element 1002 against pledgets 905, a catheterwhich is used to deliver T-bars 904 may be used to push locking element1002 into a locked position. A catheter which delivers T-bars 904 andmay also be used to engage locking element 1002 will be discussed belowwith reference to FIGS. 13 a-c.

Like locking element 1002, T-bars 904 may also be formed from abiocompatible polymer. Thread 907, which may be coupled to T-bars 904through tying T-bars 904 to thread 907 or molding T-bars 904 over thread907, may be formed from substantially any material which is typicallyused to form sutures. Suitable materials include, but are not limitedto, silk, prolene, braided Dacron, and polytetrafluoroethylene (PTFE, orGoreTex).

As mentioned above, the configuration of locking element 1002 may vary.For example, a locking element may include a spring element as shown inFIG. 11. A suture structure 1100 include T-bars 1104, a thread 1107, anda locking element 1102. For ease of illustration, the elements of suturestructure 1100 have not been drawn to scale. Although suture structure1100 is not illustrated as including a pledget, it should be appreciatedthat suture structure 1100 may include a pledget or pledgets which serveas reinforcing elements which generally support the growth of scartissue.

Locking element 1102 includes solid elements 1102 a and a spring element1102 b. Although solid elements 1102 a may be formed from abiocompatible polymer, solid elements 1102 a may also be formed frommaterial which is typically used to form pledgets. Spring element 1102 bis arranged to be held in an extended position, as shown, while a loop1114 in thread 1107 is pulled on. Once T-bars 1104 are in contact withtissue 1140, solid elements 1102 a may come into contact with tissue1140, and spring element 1102 b may contract to create a spring forcethat pulls solid elements 1102 a toward each other. In other words, onceT-bars 1104 are properly positioned against tissue 1140, locking element1102 may be locked to form a plication or local bunching of tissue 1140.

In one embodiment, the formation of scar tissue on the fibrous tissuewhich is in proximity to a mitral valve may be promoted before aplication is formed, or before the fibrous tissue is gathered tocompensate for mitral valve insufficiency. With reference to FIGS. 12a-c, a locking element which promotes the growth of scar tissue before aplication is formed will be described in accordance with an embodimentof the present invention. As shown in FIG. 12 a, a suture structure1200, which is not drawn to scale, includes a locking element 1204, athread 1207, and T-bars 1204. Locking element 1204, which includes solidelements 1202 a, a spring element 1202 b, and a resorbable polymerovermold 1202 c formed over spring element 1202 b is coupled to thread1207 on a ventricular side of tissue 1240.

Overmold 1202 c, which may be formed from a resorbable lactide polymersuch as PURASORB, which is available from PURAC America of Lincolnshire,Ill., is formed over spring element 1202 b while spring element 1202 bis in an extended position. Overmold 1202 c is arranged to remain intactwhile scar tissue 1250 forms over solid elements 1202 a. In oneembodiment, in order to facilitate the formation of scar tissue, solidelements 1202 a may be formed from material that is porous or fibrous,e.g., “pledget material.”

Once scar tissue is formed over solid elements 1202 a, overmold 1202 cbreaks down, e.g., degrades, to expose spring element 1202 b, as shownin FIG. 12 b. As will be understood by one of skill in the art, thechemical composition of overmold 1202 c may be tuned such that theamount of time that elapses before overmold 1202 c breaks down may becontrolled, e.g., controlled to break down after a desired amount ofscar tissue is expected to be formed. Hence, once overmold 1202 c breaksdown, and spring element 1202 b is allowed to contract, as shown in FIG.12 c, enough scar tissue 1250 will generally have formed over solidelements 1202 a to effectively bond solid elements 1202 a against tissue1240 to allow for the formation of a relatively strong plication orgathering of tissue 1240.

While a loop 1214 of thread 1207 may be allowed to remain extended intoa left ventricle of a heart, thread 1207 may be cut, i.e., loop 1214 maybe effectively removed, to reduce the amount of loose thread 1207 in theheart. Alternatively, loose thread 1207 may effectively be eliminated bygathering thread 1207 around a cylindrical arrangement (not shown)positioned over locking element 1202. That is, a spool or similarelement may be included as a part of suture structure 1200 to enableloose thread 1207 to either be gathered within the spool or gatheredaround the exterior of the spool.

The use of overmold 1202 c enables anchoring forces which hold T-bars1204 and locking element 1202 in position to be relatively low, assubstantially no significant forces act on tissue 1240 until after scartissue or tissue ingrowth is created. Once scar tissue is created, andovermold 1202 c has degraded, then spring 1202 b compresses. Theanchoring forces generated at this time may be relatively high. However,as scar tissue has been created, the likelihood that T-bars 1204 cutinto tissue 1240 at this time is generally relatively low.

As mentioned above, catheters may be used to deliver suture structuresinto a heart, and to engage the suture structures to tissue around themitral valve of the heart. One embodiment of a suture structure deliverycatheter which is suitable for use in a catheter-based annuloplasty thatuses local plications will be described with respect to FIG. 13 a. Adelivery catheter 1300 may be positioned over a guide wire, e.g., guidewire 802 as shown in FIG. 8, which serves as a track to enable deliverycatheter 1300 to be delivered in the gutter of a heart. It should beappreciated that the elements of delivery catheter 1302 have not beendrawn to scale. Within delivery catheter 1300 is a wire 1308 whichcarries T-bars 1304 of a suture structure. In one embodiment, T-bars1300 are coupled to a thread 1307 and a locking element 1300 to form thesuture structure. Typically, a pointed or sharpened end 1311 of wire1308 is configured to penetrate tissue (not shown), e.g., fibrous tissueof the heart near a mitral valve. Once end 1311 and T-bar 1304 arelocated above fibrous tissue, e.g., on an atrial side of a mitral valve,wire 1308 may be retracted a repositioned. After wire 1308 isrepositioned, end 1311 may once again penetrate tissue to effectivelydeposit T-bar 1304 over tissue on the atrial side of the mitral valve.

Wire 1308 or, more specifically, end 1311 may be used to pull thread1307 and to push locking element 1302 into position against tissue nearthe mitral valve. By way of example, end 1311 may pull on thread 1307until T-bars 1304 contact the tissue. Then, end 1311 may be used to locklocking element 1302 against the tissue and, as a result, create aplication in the tissue to effectively shrink the annulus of the mitralvalve.

In order to create additional plications, wire 1308 and, in oneembodiment, delivery catheter 1300, may be retracted entirely out of apatient to enable additional T-bars to be loaded onto wire 1308. Onceadditional T-bars are positioned on wire 1308, wire 1308 may bereinserted into delivery catheter 1300, and delivery catheter 1300 maybe used to enable another plication to be created in the tissue which islocated near the mitral valve.

FIG. 13 b is a representation of a second catheter which is suitable fordelivering a suture structure in accordance with an embodiment of thepresent invention. A catheter 1340, which is not drawn to scale andwhich may include a lumen (not shown) that is arranged to be insertedover a guide wire, includes two wires 1348 which are arranged tocooperate to carry a suture structure. As shown, wire 1348 a carries aT-bar 1344 a while wire 1348 b carries a T-bar 1344 b which are coupledby a thread 1347 and, together with a locking element 1342, form asuture structure. Tips 1351 of wires 1348 pass through tissue near amitral valve to deposit T-bars 1344 above the mitral valve. Once T-bars1344 are deposited, tips 1351 may be used to pull T-bars 1344 againstthe tissue, as well as to lock locking element 1342 against an oppositeside of the tissue. By way of example, tip 1351 b may be configured topull on thread 1347 while tip 1351 a pushes against locking element1342.

With reference to FIG. 13 c, a catheter arrangement which may deployT-bars from its tip will be described in accordance with an embodimentof the present invention. A catheter arrangement 1360 includes twocatheters which each carry a T-bar 1364. It should be appreciated thatthe elements of FIG. 13 c have not been drawn to scale for ease ofillustration. Specifically, catheter 1360 a carries T-bar 1364 a at itstip, while catheter 1360 b carries T-bar 1364 b at its tip. A thread1367 couples T-bars 1364 together such that a locking element 1362through which thread 1367 passes may lock T-bars 1364 substantiallyagainst tissue of a heart.

In one embodiment, catheter arrangement 1360 may require the use of twoguide wires to guide each of catheter 1360 a and catheter 1360 b intothe gutter of the heart. Alternatively, catheter 1360 a and catheter1360 b may be arranged such that both catheter 1360 a and catheter 1360b may be guided through the gutter of the heart through the use of asingle guide wire.

Catheter 1360 a is configured to push T-bar 1364 a through tissue nearthe mitral valve of the heart, and to release T-bar 1364 a once T-bar1364 a is located on an atrial side of the mitral valve. Similarly,catheter 1360 b is configured to push T-bar 1364 b through the tissue,and to release T-bar 1364 b. T-bars 1364 may be released, for example,when heat is applied to a dielectric associated with catheters 1360 thatcauses T-bars 1364 to be effectively snapped off. Alternatively, amechanical mechanism (not shown) that engages T-bars 1364 to catheters1360 may be disengaged to release T-bars 1354. Once T-bars 1364 arepositioned on the atrial side of the mitral valve, catheter 1360 may beused to pull on thread 1367 and to push on locking element 1362.

With reference to FIGS. 14 a and 14 b, the performance of anannuloplasty procedure using a catheter-based system which implantssuture structures in tissue near a mitral valve will be described inaccordance with an embodiment of the present invention. Once a patientis prepared, e.g., sedated, an annuloplasty procedure 1400 may beginwith the insertion of a delivery tube and a J-catheter into the leftventricle of the heart of the patient. The delivery tube and theJ-catheter may be inserted into the body of the patient through thefemoral artery, and threaded through the femoral artery and the aortainto the left ventricle of the heart. Generally, the J-catheter ispositioned within the delivery tube. One embodiment of the delivery tubeand a J-catheter were described above with respect to FIGS. 6 a and 6 b.As will be appreciated by those skilled in the art, the delivery tubeand the J-catheter are typically each threaded through the aortic valveto reach the left ventricle.

Once the delivery tube and the J-catheter are positioned within the leftventricle, a gutter catheter may be extended through the J-catheter instep 1408. As was discussed above with reference to FIGS. 7 a-c, thegutter catheter is arranged to effectively run against a gutter of thewall of the left ventricle substantially immediately under the mitralvalve. Specifically, the gutter catheter may be positioned in the spacein the left ventricle between the mitral valve and the musculipapillares, or papillary muscles. The gutter catheter often has a tipthat is steerable and flexible. In one embodiment, the tip of the guttercatheter may be coupled to an inflatable balloon. The J-catheter serves,among other purposes, the purpose of allowing the gutter catheter to beinitially oriented in a proper direction such that the gutter cathetermay be positioned along the wall of the left ventricle.

In step 1412, a guide wire with an anchoring feature may be deliveredthrough the gutter catheter, e.g., through a lumen or opening in thegutter catheter. The guide wire is delivered through the gutter cathetersuch that it follows the contour of the gutter catheter against the wallof the left ventricle. After the guide wire is delivered, the anchoringfeature of the guide wire is anchored on the wall of the left ventriclein step 1416. Anchoring the guide wire, or otherwise implanting theguide wire, on the wall of the left ventricle enables the guide wire tomaintain its position within the left ventricle.

The J-catheter and the gutter catheter are pulled out of the leftventricle through the femoral artery in step 1420, leaving the guidewire anchored within the left ventricle, as was discussed above withrespect to FIG. 8. A T-bar assembly delivery catheter which carries aT-bar assembly is then inserted through the femoral artery into the leftventricle over the guide wire in step 1436. In one embodiment, the T-barassembly delivery catheter carries an uninflated balloon.

After the T-bar assembly delivery catheter is inserted into the leftventricle, the balloon is inflated in step 1428. Inflating the balloon,e.g., an elastomeric balloon, at a relatively modest pressure using, forexample, an air supply coupled to the balloon through the T-bar assemblydelivery catheter, serves to enable substantially any catheter whichuses the guide wire as a track to be pressed up against the fibroustissue around the mitral valve. Generally, the inflated balloonsubstantially occupies the space between the mitral valve and thepapillary muscles. In one embodiment, more than one balloon may beinflated in the left ventricle.

Once the balloon is inflated in step 1428. The T-bar assembly deliverycatheter effectively delivers T-bars, or similar mechanisms, pledgets,and thread which are arranged to attach or otherwise couple with anannulus of the mitral valve, e.g., the fibrous tissue of the skeletonaround the mitral valve, to create plications. Suitable catheters weredescribed above with respect to FIGS. 13 a-c. In step 1440, a plicationis created using the T-bar assembly in substantially any suitable tissuenear the mitral valve. For example, a plication may be created byessentially forcing T-bars through the tissue, then locking the T-barsagainst the tissue using a locking mechanism of the T-bar assembly.Specifically, the plication or bunching of tissue may be created byextending sharpened wires which carry elements such as T-bars throughthe tissue, then retracting the sharpened wires, and pulling the T-barsinto place. Positioning the T-bars, and locking the locking mechanismcauses the tissue between the T-bars and the locking mechanism may bunchtogether.

Once the plication is created in step 1440, the balloon is generallydeflated in step 1442. The T-bar assembly delivery catheter may then beremoved through the femoral artery in step 1444. A determination is madein step 1448 after the T-bar assembly delivery catheter is removed as towhether additional plications are to be created. If it is determinedthat additional plications are to be created, then process flow returnsto step 1436 in which the T-bar assembly delivery catheter, whichcarries a T-bar assembly or suture structure, is reinserted into thefemoral artery.

Alternatively, if it is determined in step 1448 that there are no moreplications to be created, then process flow proceeds to step 1456 inwhich the guide wire may be removed. After the guide wire is removed,the delivery tube may be removed in step 1460. Once the delivery tube isremoved, the annuloplasty procedure is completed.

In lieu of using suture structures such as T-bar assemblies to createlocal plications, other elements may also be used to create localplications in fibrous tissue near the mitral valve during anannuloplasty procedure. FIG. 15 is a cut-away top view representation ofa left side of a heart in which local plications have been created usingindividual, discrete elements in accordance with an embodiment of thepresent invention. Local plication elements 1522 are effectivelyimplanted in fibrous tissue 1540 around portions of a mitral valve 1516in order to reduce the size of a gap 1508 between an anterior leaflet1520 and a posterior leaflet 1518, e.g., to reduce the arc lengthassociated with posterior leaflet 1518. Local plication elements 1522are arranged to gather sections of tissue 1540 to create localplications. The local plications created by local plication elements1522, which are generally mechanical elements, reduce the size of themitral valve annulus and, hence, reduce the size of gap 1508. As will beunderstood by those skilled in the art, over time, scar tissue may growaround or over local plication elements 1522.

The configuration of local plication elements 1522 may be widely varied.For example, local plication elements 1522 may be metallic elementswhich have spring-like characteristics, or deformable metallic elementswhich have shape memory characteristics. Alternatively, each localplication element 1522 may be formed from separate pieces which may bephysically locked together to form a plication. With reference to FIGS.16 a-d, one embodiment of a local plication element which hasspring-like characteristics will be described in accordance with anembodiment of the present invention. A local plication element 1622 maybe delivered to a ventricular side, or bottom side, of tissue 1640 whichis located near a mitral valve. When delivered, as for example through acatheter, element 1622 is in a substantially folded, closed orientation,as shown in FIG. 16 a. In other words, element 1622 is in a closedconfiguration that facilitates the delivery of element 1622 through acatheter. After an initial compressive force is applied at corners 1607of element 1622, sides or tines 1609 of element 1622 may unfold or open.As tines 1609 open, tips 1606 of tines 1609 may be pressed againsttissue 1640, as shown in FIG. 16 b. The application of compressive forceto tines 1609, as well as a pushing force to a bottom 1611 of element1622, allows tips 1606 and, hence, tines 1609 to grab tissue 1640 astips 1606 push through tissue 1640, as shown in FIG. 16 c. The closingof tines 1609, due to compressive forces applied to tines 1609, causestissue 1640 to be gathered between tines 1609 and, as a result, causes aplication 1630 to be formed, as shown in FIG. 16 d. In one embodiment,the catheter (not shown) that delivers element 1622 may be used to applyforces to element 1622.

As mentioned above, elements used to create local plications may becreated from shape memory materials. The use of a shape memory materialto create a plication element allows the plication element to beself-locking. FIG. 17 a is a representation of one plication elementwhich is formed from a shape memory material in accordance with anembodiment of the present invention. A clip 1704, which may be formedfrom a shape memory material, i.e., an alloy of nickel and titanium, isarranged to be in an expanded state or open state when it is introduced,e.g., by a catheter, into the gutter of the left ventricle. Typically,holding clip 1704 in an expanded state involves applying force to clip1704. In one embodiment, a catheter may hold sides 1708 of clip 1704 tomaintain clip 1704 in an expanded state.

Once tips 1706 of clip 1704 are pushed through the fibrous tissue nearthe mitral valve of the heart such that tips 1706 are positioned on anatrial side of the mitral valve, force may be removed from clip 1704.Since clip 1704 is formed from a shape memory material, once force isremoved, clip 1704 forms itself into its “rest” state of shape, as shownin FIG. 17 b. In its rest state or preferred state, clip 1704 isarranged to gather tissue in an opening 1712 defined by clip 1704. Thatis, the default state of clip 1704 is a closed configuration which iseffective to bunch tissue to create a local plication.

Another discrete self-locking plication element which is suitable forcreating a local plication is a clip which may twist from an openposition to a closed, or engaged position, once force applied to holdthe clip in an open position is removed. FIG. 18 a is a representationof another self-locking plication element shown in a closed position inaccordance with an embodiment of the present invention. A clip element1800, which may be formed from a material such as stainless steel or ashape memory material, is preloaded such that once tissue 1830 ispositioned in a gap 1810 between a tine 1806 and a time 1808, clipelement 1800 may return to a state which causes tissue 1830 to bepinched within a gap or space 1810.

Tine 1806 and tine 1808 first pierce tissue 1830, e.g., the tissue of anannulus of a mitral valve. As tine 1806 and tine 1808 are drawn togetherto create a plication, thereby reducing the size of gap 1810 by reducinga distance 1820, a bottom portion 1812 of clip element 1800 twists, asfor example in a quarter turn, effectively by virtue of shape memorycharacteristics of clip element 1800. Thus, an effective lock that holdstine 1806 and tine 1808 in a closed position such that tissue 1830 isgathered to form a local plication results.

In lieu of a preloaded clip element, a clip element may include a lockmechanism which engages when force is applied. FIG. 18 a is arepresentation of a self-locking plication element which includes asliding lock in accordance with an embodiment of the present invention.A clip element 1850 includes a body 1852 and a slider 1862 which isarranged to slide over at least a portion of body 1852. Clip element1850, which may be formed from a material such as stainless steel or ashape memory alloy, includes a tip 1856 and a tip 1858 which aresubstantially separated by a gap 1856 when slider 1862 is in an unlockedposition. As shown, slider 1862 is in an unlocked or open position whenslider 1862 is positioned about a tapered neck 1854 of body 1852.

When clip element 1850 is delivered into a left ventricle, e.g., using acatheter, clip element 1850 is positioned within the left ventricle suchthat tip 1856 and tip 1858 are effectively pierced through fibroustissue 1880 near the mitral valve. After tip 1856 and tip 1858 arepositioned substantially on an atrial side of tissue 1880, force may beapplied to slider 1862 to move slider 1862 in a y-direction 1870 b overbody 1852. As slider moves in y-direction 1870 b away from tapered neck1854, slider 1862 forces tip 1856 and tip 1858 together close gap 1860,i.e., tip 1856 and tip 1858 move towards each other in an x-direction1870 a. When tip 1856 and tip 1858 cooperate to close gap 1860, tissue1880 is gathered within clip element 1850, thereby creating a localplication.

In one embodiment, when slider 1862 is in a closed position such thattip 1856 and tip 1858 cooperate to close gap 1856, slider 1862 maycontact tissue 1880. Hence, in order to promote the growth of scartissue over parts of clip element 1850 or, more specifically, slider1862, at least a top surface of slider 1862 may be covered with apledget material, e.g., a mesh which supports the growth of scar tissuetherethrough.

Locking elements which create local plications may include elementswhich have two or more substantially separate pieces which lock togetheraround tissue. An example of a locking element which includes twoseparate pieces is shown in FIG. 19. As shown in FIG. 19, a lockingelement 2000 may include a receiver piece 2002 and a locker piece 2004,which may generally be formed from substantially any suitable material,as for example a biocompatible plastic material. Receiver piece 2002 andlocker piece 2004 each include a tine 2006. Tines 2006 are arranged topierce and to engage tissue to create a local plication.

A cable tie portion 2010 of locker piece 2004 is configured to be drawnthrough an opening 2008 which engages cable tie portion 2010. Opening2008 includes features (not shown) which allow cable tie portion 2010 tobe pulled through opening 2008 and locked into position, and whichprevent cable tie portion 2010 substantially from being pushed out ofopening 2008. Cable tie portion 2010 is locked in opening 2008 whenbevels 2012 come into contact and effectively force tines 2006 to clampdown. Once tines 2006 clamp down, and locker piece 2004 is lockedagainst receiver piece 2002, a local plication is formed.

The operation of locking element 2000 will be described with respect toFIGS. 20 a-d in accordance with an embodiment of the present invention.As shown in FIG. 20 a, receiver piece 2002 and locker piece 2004 may bedelivered substantially beneath fibrous tissue 2050 near a mitral valve(not shown). Receiver piece 2002 and locker piece 2004 may be deliveredusing a catheter which includes a top surface 2054. Top surface 2054 ofthe catheter is arranged to apply force to tines 2006 such that tines2006 remain in an effectively undeployed, e.g., partially bent orfolded, position while being delivered by the catheter.

Once receiver piece 2002 and locker piece 2004 are positioned undertissue 2050 near a location where a plication is to be formed, forcesare applied to receiver piece 2002 and locker piece 2004 to pushreceiver piece 2002 and locker piece 2004 together and effectivelythrough an opening 2058 in top surface 2054 of the catheter, as shown inFIG. 20 b. The forces are typically applied by mechanisms (not shown)associated with the catheter. As tines 2006 pass through opening 2058,tines 2006 “open,” or deploy in order to pierce tissue 2050.

After piercing tissue 2050, tines 2006 continue to penetrate and togather tissue 2050 while receiver piece 2002 and locker piece 2004 arepushed together. As receiver piece 2002 and locker piece 2004 are pushedtogether, cable tie portion 2010 is inserted into opening 2008 (shown inFIG. 19) of receiver portion 2002, as shown in FIG. 20 c. Cable tieportion 2010 eventually locks with respect to opening 2008 when bevels2012 come into contact. When bevels 2012 come into contact, tines 2006close inwards, causing tissue 2050 to be captured, i.e., causing a localplication 2060 to be formed. Once a local plication is formed, and forceis no longer required to push receiver piece 2002 and locker piece 2004together, the catheter which delivered receiver piece 2002 and lockerpiece 2004 may be removed from the left ventricle. Referring next toFIGS. 21 a and 21 b, an annuloplasty procedure which uses acatheter-based system to create local plications in tissue near a mitralvalve using discrete elements will be described in accordance with anembodiment of the present invention. After a patient is prepared, anannuloplasty procedure 2100 may begin with the insertion of a deliverytube and a J-catheter into the left ventricle of the heart of thepatient in step 2104. Once the delivery tube and the J-catheter arepositioned within the left ventricle, a gutter catheter may be extendedthrough the J-catheter in step 2108. The gutter catheter, as describedabove, is arranged to effectively run against a gutter of the wall ofthe left ventricle, e.g., between the mitral valve and the papillarymuscles. The gutter catheter often has a tip that is steerable andflexible.

In step 2112, a guide wire with an anchoring feature may be deliveredthrough the gutter catheter, e.g., through a lumen or opening in thegutter catheter. The guide wire is delivered through the gutter cathetersuch that it follows the contour of the gutter catheter against the wallof the left ventricle. After the guide wire is delivered, the anchoringfeature of the guide wire is anchored on the wall of the left ventriclein step 2116.

The J-catheter and the gutter catheter are pulled out of the leftventricle through the femoral artery in step 2120, leaving the guidewire anchored within the left ventricle, as was discussed above withrespect to FIG. 8. A plication element delivery catheter which carries aplication element and, in one embodiment, is arranged to engage theplication element to the fibrous tissue around the mitral valve isinserted through the femoral artery into the left ventricle over theguide wire in step 2132. The plication element delivery catheter, in thedescribed embodiment, is coupled to an uninflated balloon which isinflated in step 2134 to effectively allow the plication elementdelivery catheter to be positioned substantially directly under thefibrous tissue. Once the plication element delivery catheter ispositioned in the left ventricle, e.g., over the guide wire in thegutter of the left ventricle, and the balloon is inflated, the plicationelement delivered by the delivery catheter is engaged to the fibroustissue in step 2136. That is, the plication element is coupled to thefibrous tissue such that a local plication is formed in the fibroustissue.

After the local plication is created in step 2136 by engaging tissueusing the plication element, the balloon is deflated in step 2138. Upondeflating the balloon, the plication element delivery catheter may beremoved through the femoral artery in step 2140. A determination is thenmade in step 2142 as to whether additional local plications are to becreated. That is, it is determined if other plication elements are to beintroduced into the left ventricle. If it is determined that additionallocal plications are to be created, process flow returns to step 2132 inwhich the plication element delivery catheter, which carries anotherplication element, is reinserted into the femoral artery.

Alternatively, if it is determined in step 2142 that there are no morelocal plications to be created, then the indication is that a sufficientnumber of local plications have already been created. Accordingly, theguide wire may be removed in step 2148, and the delivery tube may beremoved in step 2152. After the delivery tube is removed, theannuloplasty procedure is completed.

A catheter which may enable an orthogonal access to a mitral valve mayenable the catheter to be more accurately positioned underneath themitral valve. As discussed above, a catheter may become at leastpartially tangled in trabeculae which are located in the left ventricleof a heart. As such, inserting a catheter which does not extend toodeeply into the left ventricle may prevent significant tangling. Anytangling may impede the efficiency with which the catheter may bepositioned beneath a mitral valve. One catheter which may be less likelyto become at least partially tangled in trabeculae, while also enablingan orthogonal access to a mitral valve, is an L-shaped catheter, whichis shown in FIG. 22 a. An L-shaped catheter arrangement 2200, whichincludes a delivery tube 2201 and an L-shaped catheter 2202 which may beformed from a biocompatible material that is typically also relativelyflexible, is arranged to allow the tip of L-catheter 2202 to maintain an“L” shape when passed through an aortic valve 2206 into a left ventricle2204. After delivery tube 2201 and L-shaped catheter 2202 areeffectively “snaked” or inserted through a femoral artery, a tip 2208 ofL-shaped catheter may be positioned at a top portion of left ventricle2204, where there is typically a minimal amount of trabeculae.

Tip 2208 of L-shaped catheter 2202 may be extended in a straightorientation such that tip 2208 effectively forms an “L” with respect todelivery tube 2201 and the remainder of L-shaped catheter 2202. In oneembodiment, as tip 2208 is extended under a mitral valve 2212, a string2210 or another part, e.g., a wire, that may be coupled to tip 2208 mayextend through an opening in delivery tube 2201 as shown in FIG. 22 b.String 2210 may effectively allow tip 2208 to be bent or otherwise movedaround underneath to position tip 2208 into contact with mitral valve2212, as shown in FIG. 22 c.

The use of string 2210 to pull on tip 2208 allows, in cooperation withextending L-shaped catheter 2202, tip 2208 to be moved beneath mitralvalve 2212 into desired positions. Hence, desired locations beneathmitral valve 2212 may relatively easily be reached to enable plications(not shown) to be created in the desired locations. In the describedembodiment, string 2210 may enable a curve to be created in L-shapedcatheter 2202 that is substantially an approximately ninety degreecurve.

L-shaped catheter 2202 may be used to create plications in mitral valve2212 using a variety of different methods. Specifically, tip 2208 ofL-shaped catheter 2202 may be temporarily fixed in a position beneathmitral valve 2212, e.g., in a gutter of the heart, during a process ofcreating a plication in mitral valve 2212. In one embodiment, suctionmay be used to gather a portion of tissue near mitral valve 2212 eithersuch that a plication may be made in the portion, or such that atemporary anchor point may be created. Suction generally enables tissueto be substantially gathered such that an apparatus, as for example aclip or a similar apparatus, may be put into place to hold the gatheredtissue. Alternatively, suction may be used to secure or firmly anchortip 2208 against mitral valve 2212 such that an anchor for a plicationmay be deployed with improved accuracy. When tip 2208 is anchored intotissue near mitral valve 2212, an anchor for a plication or a temporaryanchor may be more precisely placed, as the position of tip 2208 iseffectively fixed.

FIGS. 23 a and 23 b are diagrammatic representations of orientations ofa tip area of an L-shaped catheter which may be used with suction toanchor the tip area to a mitral valve in accordance with an embodimentof the present invention. As shown in FIG. 23 a, a tip 2308 of acatheter such as an L-shaped catheter, e.g., L-shaped catheter 2202 ofFIG. 22 c, may include an opening 2314 on a side of tip 2308. Opening2314 may be positioned under tissue 2312 such that when suction isapplied through opening 2314, tip 2308 is effectively temporarily fixedagainst tissue 2312. Alternatively, as shown in FIG. 23 b, a tip 2318 ofan L-shaped catheter may include an end opening 2324, i.e., an openingat an endpoint of tip 2318, that allows opening 2324 to contact tissue2322 such that when suction is applied through opening 2324, tip 2312 isheld relatively firmly against tissue 2322. Temporarily anchoring acatheter near a mitral valve generally allows plication elements to bemore accurately deployed using the catheter.

In lieu of using suction to anchor the tip area of a catheter to tissuenear a mitral valve, a wire with a coil which may be extended through acatheter such that the wire may be temporarily anchored into tissue nearthe mitral valve such that other catheters may track over the wire. Forexample, a wire with a helical coil or a spiral at the tip may beengaged against tissue by applying force to the tip of the wire, turningthe wire such that the helical coil portion of the wire turns throughthe tissue, the pushing the coil through the tissue. FIGS. 24 a and 24 bare diagrammatic representations of a wire with a helical coil which maybe suitable for use in as a temporary anchor that is anchored intotissue near a mitral valve in accordance with an embodiment of thepresent invention. A wire 2430 with a coiled tip 2432, as shown in FIG.24 a, may be extended through a catheter (not shown) while a tip of thecatheter may, in one embodiment, effectively be anchored against tissuenear a mitral valve. Wire 2430 may be inserted in a catheter (not shown)such that a longitudinal axis of wire 2430 is parallel to a longitudinalaxis of a tip (not shown) of the catheter. As shown in FIG. 24 b, coiledtip 2432 may extend through a lumen of a tip 2440 of an L-shapedcatheter to enable tip 2440 to be substantially anchored when coiled tip2432 is anchored against tissue. Coiled tip 2432 is incorporated in thetip of the catheter, and would be engaged by rotating the entirecatheter. This design features a working lumen that is coaxial with thecenter of the helical tip to enable a T-bar that is pushed down thelumen to pass through the center of the helix as the T-bar iseffectively forced through tissue. It should be appreciated that, in oneembodiment, a coiled tip may be included as a part of an L-shapedcatheter, i.e., the catheter may include a coiled tip.

A wire 2430 with a coiled tip 2432 may generally be used as a temporaryanchor which may remain coupled to tissue even after a catheter throughwhich wire 2430 was deployed is retracted. That is, wire 2430 may serveas a track over which other catheters may be “run” to enable aparticular position, i.e., a position identified by the location ofcoiled tip 2432 with respect to the tissue, to be repeatedly accessed orlocated by catheters.

In general, temporary fixation is a relatively reversible process. Byeffectively temporarily fixing or anchoring a catheter or a coiled tipof a wire against mitral valve tissue or tissue near a mitral valve, itis relatively easy to position, release, and re-position the wire and,hence, a catheter that tracks over the wire substantially withouttrauma, and substantially without causing an irreversible action tooccur. A temporary anchor may provide a tension or counter-tractionforce for the application of a permanent anchor. That is,counter-traction on the temporary anchor may be used to provide a tissuepenetration force for the permanent anchor. Possible permanent anchorsgenerally include both single anchor points, e.g., applying one T-barwith a second T-bar being needed to for a plications, and dual anchorpoints, e.g., applying a clip or a staple which creates a plicationbetween its points.

Once a catheter is effectively anchored into position, as for exampleover a wire such as wire 2430, then anchors which are used to createplications may be deployed. Typically, two anchor points are used toform a single plication. FIG. 25 is a diagrammatic representation of ananchor which is deployed and anchored into tissue in accordance with anembodiment of the present invention. An anchor 2504, which is coupled toa tether or a tail 2500, is deployed through tissue 2508 such thatanchor 2504 is pushed through tissue 2508 while tail 2500 is allowed toextend, e.g., to an exterior of the body of a patient. In oneembodiment, anchor 2504 may be a temporary anchor which is not actuallyused in the creation of a plication but is, instead, used to allowanchors used for plications to be positioned. In such an embodiment,anchor 2504 may be used to enable a first permanent anchor to beanchored. Alternatively, anchor 2504 may be an anchor, e.g., a T-bar,which is intended to be used to create a plication. For ease ofdiscussion, anchor 2504 is described as being a first permanent anchorthat was previously anchored into position by guiding a catheter over atemporary anchor (not shown).

An incrementor catheter may use tail 2500 as a guide over which theincrementor catheter may be positioned. An incrementor catheter, asshown in FIG. 26 a, may generally include two sections. A first section2602 of an incrementor catheter 2600, may be inserted over tail 2500. Inone embodiment, first section 2602 may be used to insert anchor 2504,e.g., when incrementor catheter 2600 is configured as an L-shapedcatheter.

Once first section 2602 is positioned over tail 2500 such that firstsection 2602 is in relatively close proximity to tissue 2508, a secondsection 2604 may be extended away from first section 2602, as forexample by a nominal separation or distance ‘d,’ as shown in FIG. 26 b.The positioning of first section 2602 over tail 2500 enables firstsection 2602 to be temporarily fixed. With first section 2602 beingtemporarily fixed, second section 2604 may be controlled such that a tipof second section 2604 may be rotated, extended, or retraced to controlthe penetration angle of an anchor (not shown) that is to be deployed.

Additionally, when first section 2602 is temporarily fixed, the positionof first section 2602 may be maintained for enough time to performsubstantially all desired tests and to withstand forces associated withthe desired test. Further, substantially all forces associated with themanipulation of incrementor catheter 2602.

Distance ‘d’ may be substantially any distance, and is typicallyselected to be a distance which allows a plication created using anchor2504 and an anchor (not shown) that is to be deployed through secondsection 2604 to be effectively created. When second section 2604 is usedto deploy either a temporary or permanent anchor (not shown), secondsection 2604 is effectively a working lumen of incrementor catheter2600.

The location of anchors may generally be verified using a number oftechnologies which include, but are not limited to, ultrasoundtechniques, fluoroscopy techniques, and electrical signals. With some ofthe technologies, the injection of marking agents, e.g., contrast agentsfor fluoroscopy or microspheres for ultrasound, may increase contrastand promote visibility. Typically, such injections may be into aventricular space, within mitral valve tissue, or in through the mitralvalve tissue into atrial space. It should be appreciated that theverification of locations may further enable a distance ‘d’ betweenconsecutive anchors to be more accurately maintained.

FIG. 27 is a diagrammatic representation of two anchors which may beused to create a plication in accordance with an embodiment of thepresent invention. Anchor 2504 and an anchor 2704, which may be deployedusing second section 2604 of incrementor catheter 2600 of FIG. 26 b, areseparated by distance ‘d.’ Each anchor 2504, 2704 has a tail section,i.e., tail 2500 and a tail 2700, respectively, which, after incrementorcatheter 2600 of FIG. 26 b is withdrawn from underneath tissue 2508, maybe pulled on or tensioned such that a plication is effectively createdbetween anchor 2504 and anchor 2704. Once a plication is created, tails2500, 2700 may be trimmed.

In general, a daisy chain of plications may be created using anincrementor catheter. That is, the incrementor catheter may be used toanchor a series of anchors which are each substantially separated by adistance ‘d.’ Once a daisy chain of anchors is in place in mitral valvetissue, pairs of the anchors may effectively be tied off to create aseries or a daisy chain of plications. With reference to FIG. 28 a-f, aprocess of creating a daisy chain of plications will be described inaccordance with an embodiment of the present invention. As shown in FIG.28 a, a first anchor 2802 a, which may be a T-bar, has a tail 2806 asuch as a suture and is anchored to tissue 2804. Typically, tissue 2804is tissue of a mitral valve annulus, or tissue near a mitral valve. Asecond anchor 2802 b, which has a tail 2806 b is also anchored intotissue 2804. Typically, the distance between second anchor 2802 b andfirst anchor 2802 a is a measured distance, i.e., the distance betweensecond anchor 2802 b and first anchor 2802 a is predetermined. In oneembodiment, the distance is substantially controlled using anincrementor catheter.

Once first anchor 2802 a and second anchor 2802 b are in place, a locker2810 a is delivered over tails 2806 a, 2806 b, as shown in FIG. 28 b.Once locker 2810 a is delivered, tail 2806 a may be tensioned,substantially locked, and trimmed. Tensioning of tail 2806 b, as shownin FIG. 28 c, allows a first plication 2820 to be effectively created.Tail 2806 b remains untrimmed, as second anchor 2802 b is arranged to beincluded in a second plication of a daisy chain of plications. That is,second anchor 2802 b may effectively be shared by more than oneplication. A third anchor 2802 c which has a tail 2806 c, as shown inFIG. 28 d, is anchored into tissue 2804 at a specified distance fromsecond anchor 2802 b, e.g., through the use of an incrementor catheter.

A locker 2810 b may be delivered over tail 2806 b and tail 2806 c, andtail 2806 b may be tensioned, locked, and trimmed as shown in FIG. 28 e.When tail 2806 c is tensioned, a second plication 2830 is created, asshown in FIG. 28 f. It should be appreciated that if tail 2806 is alsolocked and trimmed, then a daisy chain of two plications 2820, 2830 iscompleted. Alternatively, if more plications are to be added, thenadditional anchors and lockers may be positioned as appropriate suchthat tail 2806 c serves as a “starting point” for the additionalplications.

Instead of using an L-shaped catheter to create anchor points,substantially any other suitable catheter may be used to access tissuenear a mitral valve or a mitral valve annulus, e.g., to achieve asubstantially orthogonal access to mitral valve tissue. In oneembodiment, a suitable catheter may be a hook catheter which effectivelyincludes an approximately 180 degree curve may be used to create anchorpoints and plications. FIG. 29 a is a diagrammatic representation of ahook catheter in accordance with an embodiment of the present invention.A hook catheter 2900, which includes a tip 2902 that is effectively aterminus of a curved portion 2903 of hook catheter 2900, is insertedthrough an aortic valve 2904 into a left ventricle 2906.

Once hook catheter 2900 is positioned or, more specifically, once tip2902 is positioned near mitral valve tissue 2908, a string 2910 whichmay be coupled to tip 2902 as shown in FIG. 29 b, may be pulled on ortensioned and slackened, as appropriate, to enable tip 2902 to bepositioned in a desired location with respect to mitral valve tissue2908. As will be appreciated by those skilled in the art, string 2910 isoften a wire such as a pull wire or a deflection wire that is axiallytranslatable. By allowing string 2910 to enable tip 902 to be positionedin a desired location, hook catheter 2900 may effectively be consideredto be a deflectable or steerable tip catheter. A temporary anchor, e.g.,a helical coil such as helical coil 2432 of FIG. 24 a, may be anchoredto mitral valve tissue 2908 by deploying the temporary anchor throughhook catheter 2900. FIG. 29 c is a diagrammatic representation of atemporary anchor that is positioned within a heart in accordance with anembodiment of the present invention. An anchoring coil 2920, which iscoupled to a wire 2922, may be anchored to mitral valve tissue 2908 suchthat wire 2922 may serve as a guide over which a catheter, as forexample either a catheter such as a hook catheter which delivers apermanent anchor or an incrementor catheter, which may also deliver apermanent anchor, may be positioned.

In lieu of using hook catheter 2900 to deploy a temporary anchor,catheter 2900 may instead be used to deploy a more permanent anchor suchas a T-bar. As shown in FIG. 29 d, a T-bar 2940 may be pushed throughmitral valve tissue 2908 using tip 2902 of hook catheter 2900. When hookcatheter 2900 is withdrawn from left ventricle 2906, T-bar 2940effectively remains anchored in mitral valve tissue 2908, while a tail2942 of T-bar 2940 may extend to an exterior of the body of a patient,as shown in FIG. 29 e.

After T-bar 2940 or, more generally, an anchor is in position, then anincrementor catheter may be snaked or otherwise passed over tail 2942.FIG. 29 f is a diagrammatic representation of an incrementor catheterthat is positioned over tail 2942 in accordance with an embodiment ofthe present invention. An incrementor catheter 2950 is positioned suchthat a first section 2952 of incrementor catheter 2950 may be guided bytail 2942 until a tip of first section 2952 is substantially directlyunder T-bar 2940. Then, a second section 2954 of incrementor catheter2950 may be extended until a tip of second section 2954 is positionedapproximately a distance ‘d’ away from T-bar 2940. A second T-bar (notshown) or anchor may then be deployed using second section 2954. Once asecond T-bar is deployed, incrementor catheter 2950 may be removed fromleft ventricle 2906.

The use of an incrementor catheter 2950 allows two T-bars, e.g., T-bar2940 and T-bar 2980 of FIG. 29 g, to be anchored to mitral valve tissue2908 such that T-bars 2940, 2980 may be spaced apart at approximately adistance ‘d,’ while tails 2942, 2982, respectively, may extend outsideof a body of a patient. In other words, incrementor catheter 2950generally enables the distance between adjacent T-bars to be morecarefully controlled.

In order to create a plication using T-bars 2940, 2980, a locking bar2990, as shown in FIG. 29 h, may be provided over tails 2942, 2982 suchthat mitral valve tissue 2908 may effectively be pinched between T-bars2940, 2980 and locking bar 2990. Once a plication is created, tails2942, 2982 may be trimmed or otherwise cut.

With reference to FIG. 30, the steps associated with one method ofcreating a plication using an access catheter which has a 180 degreeretrograde active-curve tip, e.g., a hook catheter, an incrementorcatheter, and a helical coil for creating a temporary anchor will bedescribed in accordance with an embodiment of the present invention. Aprocess 3000 begins at step 3020 in which a catheter, e.g., a hookcatheter, is inserted in a substantially straight configuration throughan introducer into a femoral artery of a patient. Once the catheter isinserted, the tip of the catheter is prolapsed into a hook shape in step3040. A gap between an end of the hook portion and the main portion ofthe catheter may be reduced to a dimension that is small enough toprevent tangling of the tip in chords or leaflets of the heart.Prolapsing of the tip may generally occur within the aorta of a heart,at a femoral artery bifurcation, or within the left ventricle of theheart. It should be appreciated that when the tip of the catheter isdeflectable, the tip of the catheter may be deflected or substantiallyactively changed into a hook shape within the aorta of the heart, orwithin the left ventricle of the heart.

In step 3060, the tip of the catheter may be positioned within the leftventricle. By way of example, the catheter tip may be positioned at alevel that is just inferior to the level of the mitral valve annulus,and the catheter segment that includes the hook shape may be rotatedsuch that it lies against either the anterior or posterior aspect of theaortic outflow tract, depending upon which aspect is to be treated. Inone embodiment, the distal catheter segment is aligned such that whenextended, the tip of the catheter may point towards one of the entrancesto the gutter of the heart. The entrances to the gutter of the heart mayinclude substantially any relatively clear entrance to the gutter withrespect to the leaflets of the heart, as for example a medial P1location, a mid P2 location, or a lateral P3 location.

After the tip of the catheter is positioned, the tip of the catheter maybe hooked into the gutter in step 3080. Hooking the catheter tip intothe gutter may include repeatedly extending the retrograde tip toincrease the gap between the tip and the proximal segment of thecatheter, retracting the entire catheter and sensing engagement of thetip with the gutter, and, if necessary, one again positioning the tip ofthe catheter in the left ventricle before rehooking the tip.

Once the catheter tip is hooked into the gutter, the location of the tipis confirmed in step 3100. Confirming the location of the tip mayinclude, but is not limited to, as previously mentioned, sensingelectrical signals of the heart, fluoroscopy with or without theinjection of contrast, and ultrasound with or without the injection ofmicrospheres. When the tip location is confirmed, a temporary anchor maybe attached in step 3120. The temporary anchor may be a helical coil,e.g., helical coil 2432 of FIG. 24 a, that is attached by applying alongitudinal pressure and torque. Typically, when the helical coil isattached, a lumen or a tail of the helical coil remains connected to thehelical coil.

In the described embodiment, after the temporary anchor is attached, thelocation of the temporary anchor is confirmed in step 3140. Methods usedto confirm the location of the temporary anchor may be the same asmethods used to confirm the location of a catheter tip, and may alsoinclude injecting contrast or microspheres into tissue or through tissueto the atrial space above a mitral valve.

A permanent anchor is attached in step 3160 using the connection to thetemporary anchor as a guide. The permanent anchor may be attached to thesame location, and may provide a counter-traction force for tissueengagement. Like the temporary anchor, the permanent anchor generallyincludes a tail.

Once a permanent anchor is in place, an incrementor catheter isdelivered into the heart in step 3180. In general, the incrementorcatheter is delivered in a closed configuration to the location of thefirst anchor, e.g., the permanent anchor attached in step 3160, bytracking a first section of the incrementor catheter over the tail ofthe first anchor. After the incrementor catheter is delivered, theincrementor catheter may be deployed in step 3200 to create a nominaldistance or gap between the first anchor location and the working lumen,e.g., a second section, of the incrementor catheter. Then, in step 3220,a second permanent anchor may be applied at the nominal distance fromthe first permanent anchor. It should be appreciated that temporaryanchors may be used to facilitate the positioning of the secondpermanent anchor. Applying the second permanent anchor typicallyincludes retracting the incrementor catheter once the second permanentanchor is anchored into a desired location.

After both the first permanent anchor and the second permanent anchorare applied, a locker is delivered into the heart in step 3240.Delivering the locker generally includes tracking the locker or lockingdevice over the two tails of the first and the second permanent anchors.The locker may be fixed into position by applying tension to the lockerto create a plication substantially between the two permanent anchors.

Once the locker has been tensioned, the tails of the anchors may besevered, and the process of creating a plication is completed. It shouldbe appreciated that, in one embodiment, steps 3180 to 3260 may generallybe repeated to create a daisy chain of interlocking plications.

Although only a few embodiments of the present invention have beendescribed, it should be understood that the present invention may beembodied in many other specific forms without departing from the spiritor the scope of the present invention. By way of example, methods ofintroducing plication elements or suture structures into the leftventricle to correct for mitral valve leakage, or mitral valveinsufficiency, may be applied to introducing plication elements orsuture structures which correct for leakage in other valves. Forinstance, the above-described procedure may be adapted for use in repaira leaking valve associated with a right ventricle.

While creating local plications in fibrous tissue associated with themitral valve of the heart has generally been described, the plicationsmay also be created in other types of tissue which are near, around, inproximity to, or include the mitral valve. As will be appreciated bythose skilled in the art, other tissues to which plications may beformed that are near, around, in proximity to, or include the mitralvalve include tissues associated with the coronary sinus, tissuesassociated with the myocardium, or tissues associated with the wall ofthe left ventricle. In one embodiment, a plication may be substantiallydirectly formed in the leaflets of the mitral valve.

It should be understood that although a guide wire has been described asincluding an anchoring tip to anchor the guide wire to a wall of theleft ventricle, a guide wire may be anchored with respect to the leftventricle in substantially any suitable manner. By way of example, aguide wire may include an anchoring feature which is located away fromthe tip of the guide wire. In addition, a guide wire may more generallybe any suitable guiding element which is configured to facilitate thepositioning of an implant.

While access to the gutter of the left ventricle has been described asbeing associated with a minimally invasive catheter annuloplastyprocedure in which local plications are formed, it should be understoodthat the gutter of the left ventricle may also be accessed, e.g., for anannuloplasty procedure, as a part of a surgical procedure in which localplications are formed. For instance, the aorta of a heart may beaccessed through an open chest surgical procedure before a catheter isinserted into the aorta to reach the left ventricle. Alternatively,suture structures or plications elements may be introduced on aventricular side of a mitral valve through a ventricular wall which isaccessed during an open chest surgical procedure.

Pledgets have been described as being used in conjunction with, or as apart of, suture structures to facilitate the growth of scar tissue as aresult of an annuloplasty procedure. It should be appreciated, however,that the use of pledgets is optional. In addition, although pledgetshave generally not been described as being used with clip elements whichcreate local plications, it should be understood that pledgets may alsobe implemented with respect to clip elements. By way of example, a clipelement which includes tines may be configured such that the tinespierce through pledgets before engaging tissue without departing fromthe spirit or the scope of the present invention.

When a clip element has tines that are arranged to pierce through apledget before engaging tissue, the pledget may be of a hollow,substantially cylindrical shape that enables the pledget be delivered toa left ventricle over a guide wire positioned in the gutter of the leftventricle. The clip element may then be delivered by a catheter throughthe pledget. A substantially cylindrically shaped, hollow pledget whichis to be used with a suture structure may also be delivered over a guidewire, and the suture structure may then be delivered through thepledget. Delivering the suture structure through the pledget may enablea loop of thread that remains after the suture structure is locked intoplace to remain substantially within the pledget.

The configuration of clip elements may generally vary widely.Specifically, the shape of clip elements, the size of clip elements, andthe materials from which the clip elements are formed may be widelyvaried. For instance, in addition to clip elements that are formed fromshape memory material, preloaded, or self-locking using mechanicalstructures, clip elements may also be formed from thermally expandablematerials. That is, a clip may be formed such that it is in an open orflat position when delivered into a left ventricle. Such a clip may havean outer or “bottom” element that has a relatively high coefficient ofthermal expansion, and an inner or “top” element that deforms under theload generated by the outer element when heat is applied to cause theouter element to bend. Such a clip, once bent or deformed through theapplication of heat, may pierce tissue. When more heat is applied, theclip may bend more such that tissue is engaged between ends or sides ofthe clip to create a local plication. In such a system, the innermaterial may be arranged to maintain its deformed shape once heat is nolonger applied, and the heat may be applied through a catheter.

Suture structures and plication elements have been described as beingused to correct for mitral valve insufficiency. In general, suturestructures and plication elements may also be used to essentiallyprevent the onset of mitral valve insufficiency. That is, localplications may be created to effectively stem the progression of mitralvalve insuffiency be reinforcing the perimeter of the annulus around themitral valve.

While suture structures that include T-bars, thread, and lockingelements, and are delivered to a left ventricle using a catheter, may beused to form discrete plications in fibrous tissue around the mitralvalve, it should be appreciated that sutures may also be sewn into thefibrous tissue. For example, a catheter which is inserted into the leftventricle through the aorta may be configured to sew sutures into thefibrous tissue using mechanisms carried by the catheter. Such suturesthat are sewn into the fibrous tissue may be sewn in any conventionalorientation, e.g., in an arc along the perimeter of the posteriorleaflet of the mitral valve.

Suture structures that include T-bars have generally been described asincluding two T-bars which are located at ends of a thread, with alocking element and pledgets located therebetween, as shown, forexample, in FIG. 10 a. The configuration of suture structures, however,may vary widely. By way of example, a suture structure with two T-barsmay include one T-bar at one end of the thread and a second T-bar whichis located along the length of the thread such that pulling on a looseend of the thread pulls the two T-bars together. Alternatively, a suturestructure may include more than two T-bars.

In general, the use of a single element type to create local plicationsduring an annuloplasty procedure has been described. It should beunderstood that in one embodiment, different element types may be usedin a single annuloplasty procedure. For instance, both clip elements andsuture elements may be used to create plications during a singleannuloplasty procedure. Alternatively, different types of clip elementsor different types of suture elements may be used during a particularannuloplasty procedure.

The steps associated with performing a catheter-based annuloplasty maybe widely varied. Steps may generally be added, removed, reordered, andaltered without departing from the spirit or the scope of the presentinvention. Therefore, the present examples are to be considered asillustrative and not restrictive, and the invention is not to be limitedto the details given herein, but may be modified within the scope of theappended claims.

1. A method for performing annuloplasty, the method comprising: creatinga first plication in the tissue near a mitral valve of a heart, thefirst plication being created using at least a first plication element;and creating a second plication in the tissue near the mitral valve,wherein the second plication is substantially coupled to the firstplication.
 2. The method of claim 1 further including: accessing a leftventricle of the heart to provide the first plication element to theleft ventricle; and engaging the first plication element to the tissuenear the mitral valve, wherein engaging the first plication elementincludes causing the first plication element to substantially passthrough a portion of the tissue to substantially anchor the firstplication element to the tissue near the mitral valve.
 3. The method ofclaim 2 wherein the first plication element is an anchor arrangementwith a tail, and creating the first plication in the tissue near themitral valve includes: accessing the left ventricle of the heart toprovide a second plication element to the left ventricle, the secondplication element being an anchor arrangement with a tail; engaging thesecond plication element to the tissue near the mitral valve, the secondplication element being separated from the first plication element by afirst distance, wherein engaging the second plication element includescausing the second plication element to substantially pass through thetissue to substantially anchor the second plication element to thetissue near the mitral valve; and providing a first locker element overthe tail of the first plication element and the tail of the secondplication element.
 4. The method of claim 3 wherein creating the secondplication in the tissue near the mitral valve includes: accessing theleft ventricle of the heart to provide a third plication element to theleft ventricle, the third plication element being an anchor arrangementwith a tail; engaging the third plication element to the tissue near themitral valve, the third plication element being separated from thesecond plication element by a second distance, wherein engaging thethird plication element includes causing the third plication element tosubstantially pass through the tissue to substantially anchor the thirdplication element to the tissue near the mitral valve; and providing asecond locker element over the tail of the second plication element andthe tail of the third plication element.
 5. The method of claim 4wherein the first distance and the second distance are approximately thesame.
 6. The method of claim 2 wherein the first plication element isdelivered to the left ventricle using a catheter.
 7. The method of claim5 wherein the catheter has a deflectable tip.
 8. The method of claim 2further including: accessing the left ventricle using an incrementorcatheter, the incrementor catheter including a first section and asecond section, wherein the first section is arranged to be tracked overa tail of the first plication element.
 9. The method of claim 8 furtherincluding: deploying the incrementor catheter, wherein deploying theincrementor catheter includes positioning a tip of the second section atthe first distance distance away from a tip of the first section.
 10. Amethod for performing annuloplasty, the method comprising: accessing aheart to provide a plurality of plication elements to the heart, theplurality of plication elements being provided to the heart through acatheter arrangement, the plication elements including a first anchorarrangement; engaging the first anchor arrangement to tissue near amitral valve of the heart using the catheter arrangement tosubstantially anchor the first anchor arrangement to the tissue near themitral valve; and creating at least a first plication and a secondplication using the first anchor arrangement.
 11. The method of claim 10wherein engaging the first anchor arrangement includes causing the firstanchor arrangement to substantially pass through the tissue near themitral valve.
 12. The method of claim 11 wherein the plurality ofplication elements includes a first locking element and a second lockingelement, and accessing the heart to provide the plurality of elements tothe heart includes: accessing a left ventricle of the heart to providethe first locking element to the left ventricle; substantially deployingthe first locking element over the first anchor arrangement to createthe first plication; and substantially deploying the second lockingelement over the first anchor arrangement to create the secondplication.
 13. The method of claim 12 wherein the first anchorarrangement includes a tail portion, and substantially deploying thefirst locking element over the first anchor arrangement includessubstantially deploying the first locking element over the tail portionand substantially deploying the second locking element over the secondanchor arrangement includes substantially deploying the second lockingelement over the tail portion.
 14. The method of claim 13 whereincreating at least the first plication and the second plication using thefirst anchor arrangement includes: applying tension to the tail portionto create the first plication using the first locking element; andapplying tension to the tail portion to create the second plicationusing the second locking element.
 15. The method of claim 14 whereintension is applied to the tail portion to create the first plication andto create the second plication substantially simultaneously.
 16. Themethod of claim 10 wherein the catheter arrangement has a deflectabletip.
 17. A method for performing annuloplasty, the method comprising:accessing an area of a heart using a catheter arrangement, the catheterarrangement including a first portion; temporarily anchoring the firstportion of the catheter arrangement to the tissue near the mitral valveof the heart; providing an anchor element to the area; and engaging theanchor element to the tissue near the mitral valve, wherein the firstportion of the catheter arrangement is arranged to substantially providea counter-traction force associated with engaging the anchor element.18. The method of claim 17 wherein engaging the anchor element to thetissue near the mitral valve includes causing the anchor element tosubstantially pass through a portion of the tissue near the mitral valveto substantially anchor the anchor element to the tissue near the mitralvalve.
 19. The method of claim 18 wherein the area is a left ventricleof the heart.
 20. The method of claim 19 further including:substantially detaching the first portion of the catheter arrangementfrom the tissue near the mitral valve.
 21. The method of claim 19wherein the first portion of the catheter arrangement is a tip of thecatheter arrangement.
 22. The method of claim 19 wherein the firstportion of the catheter arrangement is a coiled wire of the catheterarrangement.
 23. The method of claim 19 wherein providing the anchorelement to the left ventricle includes providing the anchor elementusing the catheter arrangement.
 24. The method of claim 23 wherein thecatheter arrangement has a deflectable tip and a pull wire arranged todeflect the deflectable tip to position one of the anchor element andthe first portion.
 25. A method for performing annuloplasty, the methodcomprising: accessing an area of a heart using a catheter arrangement,the catheter arrangement including a first portion; temporarilyanchoring the first portion of the catheter arrangement to the tissuenear the mitral valve of the heart; providing an anchor element to thearea; and engaging the anchor element to the tissue near the mitralvalve, wherein the first portion of the catheter arrangement is arrangedto substantially position a tip of the catheter arrangement at thetissue near the mitral valve.
 26. The method of claim 25 whereinengaging the anchor element to the tissue near the mitral valve includescausing the anchor element to substantially pass through a portion ofthe tissue near the mitral valve to substantially anchor the anchorelement to the tissue near the mitral valve.
 27. The method of claim 26wherein the area is a left ventricle of the heart.
 28. The method ofclaim 27 further including: substantially detaching the first portion ofthe catheter arrangement from the tissue near the mitral valve.
 29. Themethod of claim 27 wherein the first portion of the catheter arrangementis the tip of the catheter arrangement.
 30. The method of claim 27wherein the first portion of the catheter arrangement is a coiled wireof the catheter arrangement.
 31. The method of claim 27 whereinproviding the anchor element to the left ventricle includes providingthe anchor element using the catheter arrangement.
 32. The method ofclaim 31 wherein the catheter arrangement has a deflectable tip and apull wire arranged to deflect the deflectable tip to position one of theanchor element and the first portion.
 33. A method for performingannuloplasty, the method comprising: accessing an area of a heart toprovide a first plication element to the area using a catheterarrangement, the catheter arrangement including a first portion and asecond portion; substantially anchoring the first portion of thecatheter arrangement to tissue near a mitral valve of the heart;positioning a tip of the second portion of the catheter arrangement at afirst distance from the first portion; and substantially engaging thefirst anchor to the tissue near the mitral valve of the heart using thesecond portion of the catheter arrangement.
 34. The method of claim 33wherein substantially anchoring the first portion of the catheterarrangement to tissue near the mitral valve of the heart includes:positioning the first portion of the catheter arrangement over a guide,the guide being substantially anchored to the tissue near the mitralvalve.
 35. The method of claim 33 wherein the first anchor includes atail, the method further including: substantially unanchoring the firstportion of the catheter arrangement from tissue near a mitral valve ofthe heart; positioning the first portion of the catheter arrangementover the tail; positioning the tip of the second portion of the catheterarrangement at a second distance from the first portion; andsubstantially engaging a second anchor to the tissue near the mitralvalve of the heart using the second portion of the catheter arrangement.36. The method of claim 35 further including: creating a plication usingat least the first anchor and the second anchor.
 37. A method forperforming annuloplasty, the method comprising: accessing an area of aheart to provide a first plication element to the area using a catheterarrangement, the catheter arrangement including a deflectable tip areaand a pull wire arranged to cause the deflectable tip area to deflect;altering a curvature in the tip area to reach tissue near a mitral valveof the heart, wherein altering the curvature includes substantiallyactively controlling the pull wire; and engaging the first plicationelement to the tissue near the mitral valve.
 38. The method of claim 37wherein engaging the first plication element includes causing the firstplication element to substantially pass through a portion of the tissueto substantially anchor the first plication element to the tissue nearthe mitral valve.
 39. The method of claim 38 wherein the area is a leftventricle of the heart.
 40. The method of claim 38 wherein the catheterarrangement is a hook catheter arrangement, the tip area beingsubstantially shaped as a hook.
 41. The method of claim 40 wherein thecatheter arrangement further includes a temporary anchor, and the methodfurther includes: deploying the temporary anchor; and substantiallytemporarily anchoring the temporary anchor to the tissue near the mitralvalve.
 42. The method of claim 41 wherein the method further includes:unanchoring the temporary anchor from the tissue near the mitral valve.43. The method of claim 40 further including: deploying an anchorelement through the catheter arrangement; and anchoring the anchorelement to the tissue near the mitral valve.
 44. A method for performingannuloplasty, the method comprising: accessing an area of a heart usinga catheter arrangement, the catheter arrangement including a deflectabletip portion and a pull wire arranged to cause the deflectable tip areato deflect; altering a curvature in the tip area to reach tissue near amitral valve of the heart, wherein altering the curvature includessubstantially actively controlling the pull wire to position the tiparea; and temporarily engaging the tip area to the tissue near themitral valve, wherein temporarily engaging the tip area to the tissuenear the mitral valve enables the catheter arrangement to deliver atleast a first plication element to the tissue near the mitral valve. 45.The method of claim 44 further including engaging the first plicationelement to the tissue near the mitral valve, wherein engaging the firstplication element includes causing the first plication element tosubstantially pass through a portion of the tissue to substantiallyanchor the first plication element to the tissue near the mitral valve.46. The method of claim 45 wherein the area is a left ventricle of theheart.
 47. The method of claim 45 wherein the catheter arrangement is ahook catheter arrangement, the tip area being substantially shaped as ahook.
 48. A method for performing annuloplasty, the method comprising:accessing a left ventricle of a heart to provide a first plicationelement to the left ventricle using a catheter arrangement; creating acurvature in the catheter arrangement to reach tissue near a mitralvalve of the heart, the curvature being at an orthogonal orientationwith respect to the mitral valve; and engaging the first plicationelement to the tissue near the mitral valve, wherein engaging the firstplication element includes causing the first plication element tosubstantially pass through a portion of the tissue to substantiallyanchor the first plication element to the tissue near the mitral valve.49. The method of claim 48 wherein creating the curvature includescreating approximately a 180 degree curve in the catheter arrangement.50. The method of claim 48 further including: accessing the leftventricle using an incrementor catheter, the incrementor catheterincluding a first section and a second section, wherein the firstsection is arranged to be tracked over a tail of the first plicationelement.
 51. The method of claim 50 further including: deploying theincrementor catheter, wherein deploying the incrementor catheterincludes positioning a tip of the second section at a distance away froma tip of the first section.
 52. The method of claim 51 furtherincluding: engaging a second plication element to the tissue atapproximately the distance away from the first plication element usingthe second section.
 53. The method of claim 52 further including:creating a plication using the first plication element and the secondplication element.
 54. An incrementor catheter comprising: a firstlumen, the first lumen being arranged to track over a wire, the wirebeing substantially anchored within a left ventricle of a heart; and asecond lumen, the second lumen having a second tip that is arranged tobe moved at a distance away from a first tip of the first lumen, whereinthe second lumen is arranged to carry and to deploy a plication element.55. A method for performing annuloplasty comprising: temporarily fixinga helical coil of a first element in tissue near a mitral valve of theheart, the first element including a tail; and tracking a catheterarrangement over the tail, wherein the catheter arrangement is arrangedto substantially permanently fix a second element to the tissue.
 56. Themethod of claim 55 wherein the catheter arrangement is an incrementorcatheter.
 57. The method of claim 55 wherein temporarily fixing thehelical coil of the first element includes using one of an L-shapedcatheter and a hook catheter to temporarily fix the helical coil.
 58. Anincrementor catheter comprising: a main catheter, and first and seconddistal catheter portions coupled with the main catheter, the first andsecond distal catheter portions having respective first and secondlumens, the second distal catheter portion arranged to be movedlaterally a first distance away from the first distal catheter portion,an elongate guide member receivable in the first lumen, and a firstplication element receivable in and deployable from the second lumen.59. The incrementor catheter of claim 58, wherein the elongate guidemember further comprises a guide wire.
 60. The incrementor catheter ofclaim 58, wherein the elongate guide member further comprises a tethercoupled with a tissue anchor.
 61. The incrementor catheter of claim 60,wherein the tissue anchor further comprises a temporary anchor.
 62. Theincrementor catheter of claim 60, wherein the tissue anchor furthercomprises a second plication element.
 63. The incrementor catheter ofclaim 62, wherein the first and second plication elements are T-bars.64. The incrementor catheter of claim 62 further comprising a lockerconfigured to couple the first and second plication elements together.